| 1 |
NCT01015521 |
Withdrawn |
Efficacy Study of Aminoflavone Prodrug to Treat Breast Cancer |
|
- Drug: Aminoflavone Prodrug
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical Benefit Response
- Progression Free Survival
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01015521 |
TG-AFP-002 |
|
April 2010 |
December 2012 |
|
November 18, 2009 |
November 3, 2010 |
|
|
| 2 |
NCT01580644 |
Completed |
Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers |
|
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug
- The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food
- The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food)
- (and 5 more...)
|
12 |
Male |
18 Years to 50 Years (Adult) |
NCT01580644 |
GLPG0187-CL-104 |
|
January 2012 |
March 2012 |
March 2012 |
April 19, 2012 |
April 20, 2012 |
|
- SGS Stuivenberg
Antwerp, Belgium
|
| 3 |
NCT01813461 |
Completed |
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects |
- Pharmacokinetics of 14C-labeled Isavuconazole
- Healthy Subjects
|
- Drug: 14C-labeled prodrug isavuconazonium sulfate
|
Interventional |
Phase 1 |
- Astellas Pharma Global Development, Inc.
- Basilea Pharmaceutica International Ltd
- Astellas Pharma Inc
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
|
- Radioactivity in whole blood and in plasma: Area under the concentration-time curve (AUC) from time of dosing to infinity (AUCinf)
- Radioactivity in whole blood and in plasma: AUC from time of dosing to the last quantifiable concentration (AUClast)
- Radioactivity in whole blood and in plasma: Maximum concentration (Cmax)
- (and 9 more...)
|
8 |
Male |
18 Years to 55 Years (Adult) |
NCT01813461 |
9766-CL-0016 |
|
October 2012 |
November 2012 |
November 2012 |
March 19, 2013 |
March 19, 2013 |
|
- Covance
Madison, Wisconsin, United States
|
| 4 |
NCT03051282 |
Recruiting |
Genetic Determinants of ACEI Prodrug Activation |
|
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- The measurements of the mean area under the curve (AUC) of enalaprilat plasma concentrations
- The measurements of the maximum enalaprilat plasma concentrations
- The measurements of angiotensin converting enzyme (ACE) activity in plasma
- The measurements of blood pressures (BPs) following enalapril treatment
|
36 |
All |
18 Years to 55 Years (Adult) |
NCT03051282 |
HUM00114879 |
|
April 1, 2017 |
January 2021 |
January 2021 |
February 13, 2017 |
April 17, 2017 |
|
- University of Michigan
Ann Arbor, Michigan, United States
|
| 5 |
NCT01546051 |
Completed |
A Study of BCI-838 and Several BCI-632 Prodrugs in Healthy Volunteers |
|
- Drug: BCI-838
- Drug: BCI-1038, BCI-1206 & BCI-1283
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Safety
- Cmax, tmax, t1/2 , AUC, CL/F, Vz/F, and Kel of BCI-838 and BCI-632
|
31 |
Male |
18 Years to 55 Years (Adult) |
NCT01546051 |
BCI-632-CL-002 |
|
October 2011 |
January 2012 |
February 2012 |
March 7, 2012 |
March 7, 2012 |
|
- PRA International
Zuidlaren, Netherlands
|
| 6 |
NCT00634231 |
Active, not recruiting |
A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors |
- Malignant Glioma
- Recurrent Ependymoma
|
- Biological: AdV-tk
- Drug: valacyclovir
- Radiation: Radiation
|
Interventional |
Phase 1 |
- Advantagene, Inc.
- Boston Children’s Hospital
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety based on standard laboratory and clinical adverse event monitoring
- Overall survival
- Progression-free survival
- (and 2 more...)
|
12 |
All |
3 Years to 21 Years (Child, Adult) |
NCT00634231 |
07-098 |
|
April 2010 |
December 2015 |
December 2020 |
March 12, 2008 |
January 10, 2018 |
|
- Ann & Robert H. Lurie Children's Hospital of Chicago (Formerly Children's Memorial Hospital)
Chicago, Illinois, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States
|
| 7 |
NCT00002415 |
Completed |
Safety and Effectiveness of Adding PMPA Prodrug to an Anti-HIV Drug Combination to Treat HIV-Infected Patients |
|
- Drug: Tenofovir disoproxil fumarate
|
Interventional |
Phase 2 |
- Gilead Sciences
- NIH AIDS Clinical Trials Information Service
|
Industry |
- Masking: Double
- Primary Purpose: Treatment
|
|
175 |
All |
18 Years to 65 Years (Adult) |
NCT00002415 |
283B
GS-98-902 |
|
|
|
|
August 31, 2001 |
June 24, 2005 |
|
- Univ of Alabama at Birmingham / 1917 Rsch Cln
Birmingham, Alabama, United States - McDowell Clinic
Phoenix, Arizona, United States - East Bay AIDS Ctr
Berkeley, California, United States - (and 21 more...)
|
| 8 |
NCT01705002 |
Active, not recruiting |
Intravenously Administered Pegylated Liposomal Mitomycin-C Lipid-based Prodrug (PROMITIL) in Cancer Patients With Solid Tumors. |
- Cancer
- Solid Tumor
- Metastatic Colorectal Cancer (mCRC)
|
- Drug: Promitil
- Drug: Capecitabine
- Drug: Bevacizumab
|
Interventional |
Phase 1 |
- Lipomedix Pharmaceuticals Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximal Tolerated Dose (MTD) of PROMITIL
- Dose Limiting Toxicity (DLT) of PROMITIL
- Pharmacokinetic (PK) profile of PROMITIL
- (and 2 more...)
|
90 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01705002 |
PROMITIL-01 |
|
October 2012 |
March 2018 |
May 2018 |
October 12, 2012 |
February 13, 2018 |
|
- Rambam Health Care Campus
Haifa, Israel - Shaare Zedek Medical Center
Jerusalem, Israel - Chaim Sheba Medical center
Ramat Gan, Israel - Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel
|
| 9 |
NCT00517439 |
Completed |
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection. |
|
- Drug: Copegus
- Drug: Pegasys
- Drug: RO4588161
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Sustained virological response (SVR)
- Virological response over time
- SVR
- (and 2 more...)
|
516 |
All |
18 Years to 65 Years (Adult) |
NCT00517439 |
NV19865 |
|
December 2007 |
January 2010 |
January 2010 |
August 17, 2007 |
November 2, 2016 |
|
- Phoenix, Arizona, United States
- La Jolla, California, United States
- Long Beach, California, United States
- (and 60 more...)
|
| 10 |
NCT00002396 |
Unknown † |
The Safety and Effectiveness of PMPA Prodrug in HIV-Infected Patients |
|
- Drug: Tenofovir disoproxil fumarate
|
Interventional |
Phase 1 |
- Gilead Sciences
- NIH AIDS Clinical Trials Information Service
|
Industry |
- Masking: Double
- Primary Purpose: Treatment
|
|
60 |
All |
18 Years to 60 Years (Adult) |
NCT00002396 |
283A
GS-97-901 |
|
|
|
|
August 31, 2001 |
June 24, 2005 |
|
- San Francisco Gen Hosp
San Francisco, California, United States - Johns Hopkins Hosp
Baltimore, Maryland, United States - Univ of Washington / AIDS Clinical Trial Unit
Seattle, Washington, United States
|
| 11 |
NCT00377182 |
Completed |
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection. |
|
- Drug: Copegus
- Drug: PEGASYS
- Drug: RO5024048 1500mg
- Drug: RO5024048 3000mg
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Adverse events (AEs) and laboratory parameters.
- Plasma concentration of HCV polymerase inhibitor
- Antiviral activity
|
107 |
All |
18 Years to 65 Years (Adult) |
NCT00377182 |
PV18369 |
|
September 2006 |
August 2008 |
August 2008 |
September 18, 2006 |
November 2, 2016 |
|
- La Jolla, California, United States
- Long Beach, California, United States
- Sacramento, California, United States
- (and 15 more...)
|
| 12 |
NCT01497444 |
Active, not recruiting |
Sorafenib Tosylate and Hypoxia-Activated Prodrug TH-302 in Treating Patients With Advanced Kidney Cancer or Liver Cancer That Cannot Be Removed By Surgery |
- Kidney Cancer
- Liver Cancer
|
- Drug: hypoxia-activated prodrug TH-302
- Drug: sorafenib tosylate
|
Interventional |
Phase 1 |
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
- Threshold Pharmaceuticals
|
Other / NIH / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of dose-limiting toxicity incidents as assessed by CTCAE version 4.0 (Phase I)
- MTD of sorafenib tosylate and TH-302 (Phase I)
- Overall response rate (Phase II)
- (and 6 more...)
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT01497444 |
N1153
NCCTG-N1153
CDR0000720022
NCI-2012-00095
U10CA031946 |
|
May 2012 |
January 2016 |
|
December 22, 2011 |
February 27, 2018 |
|
- Mayo Clinic Scottsdale
Scottsdale, Arizona, United States - Mayo Clinic Cancer Center
Rochester, Minnesota, United States
|
| 13 |
NCT01149915 |
Completed |
Study of Hypoxia-Activated Prodrug TH-302 to Treat Advanced Leukemias |
- Acute Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia
- (and 3 more...)
|
|
Interventional |
Phase 1 |
- Threshold Pharmaceuticals
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To determine the maximum tolerated dose of TH-302
- To determine the dose-limiting toxicity of TH-302
- TO determine the number of participants with Adverse Events as a measure of safety and tolerability
- To determine the efficacy of TH-302 via specific response criteria
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT01149915 |
TH-CR-407 |
|
June 2010 |
August 2013 |
August 2013 |
June 24, 2010 |
May 7, 2015 |
|
- University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
|
| 14 |
NCT01099904 |
Completed |
A Study on the Effect of Renal Function on the Pharmacakokinetics of RO5024048 (Parent of Prodrug RO5024048) Following Multiple Oral Dose Administration of RO5024048 |
|
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Phrmacokinetics of RO49958855 (parent molecule) and metabolites following multiple doses of RO5024048: AUC, Cmax, Tmax T1/2, Ae, Cl
- Effect of renal impairment on safety and tolerability: Adverse events, vital signs, ECG, laboratory parameters
|
30 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT01099904 |
PP21536 |
|
March 2010 |
September 2010 |
September 2010 |
April 8, 2010 |
November 2, 2016 |
|
- Orlando, Florida, United States
- Knoxville, Tennessee, United States
- Christchurch, New Zealand
|
| 15 |
NCT02170974 |
Completed |
Bioavailability of BIBR 953 ZW After BIBR 1048 (Oral Pro-drug of BIBR 953 ZW) Administered as Hydroxypropyl Methylcellulose (HPMC) Polymorph II Capsule Relative to HPMC Polymorph I Capsule in Healthy Subjects. |
|
- Drug: BIBR 1048 MS polymorph II
- Drug: BIBR 1048 MS polymorph I
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUC0-infinity (area under the plasma concentration-time curve of BIBR 953 ZW from 0 to infinity)
- AUC0-tz
- Cmax (maximum measured plasma concentration of BIBR 953 ZW)
- (and 9 more...)
|
28 |
All |
18 Years to 55 Years (Adult) |
NCT02170974 |
1160.52 |
|
July 2004 |
August 2004 |
|
June 23, 2014 |
June 23, 2014 |
|
|
| 16 |
NCT02674581 |
Completed |
A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction |
- Infection, Human Immunodeficiency Virus
|
- Drug: Oral BMS-663068 (pro-drug)
|
Interventional |
Phase 1 |
- ViiV Healthcare
- Covance
- GlaxoSmithKline
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effect of Renal Impairment on The Primary Endpoints of Cmax
- Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests.
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02674581 |
206217
AI438-070 |
|
March 10, 2016 |
May 24, 2016 |
May 24, 2016 |
February 4, 2016 |
May 3, 2017 |
|
- GSK Investigational Site
Miami, Florida, United States
|
| 17 |
NCT00625430 |
Unknown † |
A Phase I Gene Therapy Study of FP253/Fludarabine for Prostate Cancer |
|
- Biological: Gene Directed Enzyme Prodrug Therapy, FP253/Fludarabine
|
Interventional |
Phase 1 |
- Biotech Equity Partners Pty Ltd
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events will be recorded. Physical examinations, 12-lead ECG, vital sign monitoring, urinalysis and collection of blood samples for pathology testing will be performed. Viral DNA and infectious virus will be monitored in serum and urine samples.
- Assess haematological and immunological markers, including Prostate-Specific Antigen (PSA) and C-ReactiveProtein (CRP). Effects on tumor response and survival. Immunopathological Markers. ECOG assessment. Assessment of disease progression and survival.
|
18 |
Male |
18 Years and older (Adult, Senior) |
NCT00625430 |
253/001 |
FP253-GDEPT |
March 2008 |
December 2012 |
December 2012 |
February 28, 2008 |
July 11, 2011 |
|
- St Vincent's Hospital, Sydney
Darlinghurst, New South Wales, Australia
|
| 18 |
NCT00878020 |
Completed |
Safety Study to Evaluate BMS-830216 in Healthy Subjects |
|
- Drug: BMS-830216
- Drug: Placebo
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results
- Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose
|
48 |
All |
18 Years to 45 Years (Adult) |
NCT00878020 |
MB123-001 |
|
May 2009 |
September 2009 |
September 2009 |
April 8, 2009 |
February 23, 2011 |
|
- Ppd Development, Lp
Austin, Texas, United States
|
| 19 |
NCT00377741 |
Completed
Has Results |
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis. |
- Cytomegalovirus Infections
|
- Drug: valganciclovir [Valcyte]
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)
- Maximum Observed Plasma Concentration (Cmax) of Ganciclovir
- Time to Maximum Observed Plasma Concentration (Tmax) of Ganciclovir
- (and 2 more...)
|
31 |
All |
14 Years and older (Child, Adult, Senior) |
NCT00377741 |
WP18046 |
|
December 2004 |
June 2006 |
June 2006 |
September 18, 2006 |
December 31, 2015 |
December 31, 2015 |
- Los Angeles, California, United States
- Denver, Colorado, United States
- Durham, North Carolina, United States
- (and 2 more...)
|
| 20 |
NCT01489228 |
Unknown † |
Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease |
- Chronic Chagas Disease, Indeterminate
|
- Drug: E1224
- Drug: Benznidazole
- Drug: Placebo
|
Interventional |
Phase 2 |
- Drugs for Neglected Diseases
- Eisai Co., Ltd.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Serial negative qualitative Polymerase Chain Reaction (PCR) results (3 negative PCR results from 3 samples to be collected over 7 days) as a measure of parasitological cure at end of treatment
- Consistently negative serial qualitative PCR as a measure of sustained parasitological eradication
- Qualitative PCR as a measure of parasite eradication
- (and 8 more...)
|
230 |
All |
18 Years to 50 Years (Adult) |
NCT01489228 |
DNDi-CH-E1224-001 |
|
June 2011 |
August 2012 |
December 2013 |
December 9, 2011 |
December 21, 2011 |
|
- Plataforma de Atención Integral a los Pacientes con Enfermidad de Chagas
Cochabamba, Bolivia - Plataforma de Atención Integral a los Pacientes con Enfermidad de Chagas
Tarija, Bolivia
|
| 21 |
NCT02454712 |
Recruiting |
Study of PF614 Compared to OxyContin® in Healthy Volunteers |
|
- Drug: PF614
- Drug: Oxycodone extended-release
- Drug: Naltrexone Hydrochloride
|
Interventional |
Phase 1 |
- Ensysce Biosciences
- PRA Health Sciences
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety
- Pharmacokinetics (Cmax)
- Pharmacokinetics (Tmax)
- (and 7 more...)
|
64 |
All |
18 Years to 50 Years (Adult) |
NCT02454712 |
PF614-101 |
SAD |
November 16, 2016 |
January 5, 2018 |
January 5, 2018 |
May 27, 2015 |
December 5, 2017 |
|
- PRA Health Sciences - Early Development Services
Lenexa, Kansas, United States
|
| 22 |
NCT01954615 |
Completed |
Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects |
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
|
- Drug: 5 mg ACT-281959 prodrug formulation I (Group A)
- Drug: 20 mg ACT-281959 prodrug formulation I (Group B)
- Drug: ACT-281959 prodrug formulation I (Groups C to G doses to be defined)
- (and 3 more...)
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in supine systolic blood pressure from baseline up to the end of study
- Change in supine diastolic blood pressure from baseline up to the end of study
- Change in supine pulse rate from baseline up to the end of study
- (and 12 more...)
|
49 |
Male |
18 Years to 45 Years (Adult) |
NCT01954615 |
AC-075-101 |
|
October 2011 |
March 2012 |
March 2012 |
October 7, 2013 |
October 10, 2013 |
|
|
| 23 |
NCT00002222 |
Completed |
A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS |
- Cytomegalovirus Retinitis
- HIV Infections
|
|
Interventional |
Not Applicable |
- Hoffmann-La Roche
- NIH AIDS Clinical Trials Information Service
|
Industry |
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT00002222 |
268B |
|
|
|
|
August 31, 2001 |
June 24, 2005 |
|
- Cornell AIDS Clinical Trials Unit
New York, New York, United States
|
| 24 |
NCT02454842 |
Terminated |
Study for Treatment of Patients With EGFR Mutant, T790M-negative NSCLC |
- Non-small Cell Lung Cancer
- NSCLC
- Non-squamous NSCLC
|
- Drug: TH-4000 (Tarloxotinib)
|
Interventional |
Phase 2 |
- Threshold Pharmaceuticals
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with response rate as evaluated by RECIST criteria
- Incidence of adverse events (AEs)
- Type of adverse events (AEs)
- (and 8 more...)
|
37 |
All |
18 Years and older (Adult, Senior) |
NCT02454842 |
TH-CR-601 |
TH-4000 |
June 2015 |
January 2017 |
January 31, 2017 |
May 27, 2015 |
February 27, 2017 |
|
- University of Southern California-Norris
Los Angeles, California, United States - St. Joseph Heritage Healthcare
Santa Rosa, California, United States - University of Colorado Cancer Center
Aurora, Colorado, United States - (and 9 more...)
|
| 25 |
NCT00978965 |
Active, not recruiting |
Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs |
|
|
Observational |
|
- Medical University of Vienna
- Novartis
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Detection of functionally relevant SNPs in IMPDH 2 gene.
- The association of detected SNPs in inosine monophosphate dehydrogenase-2 transcript or high IMPDH 2 activity with the lack of response to MPA therapy defined as - number of biopsy proven acute rejections in the first year after transplantation
- Screening for strongyloides IgG titers
|
250 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00978965 |
MPASNPVienna |
|
October 2009 |
December 2018 |
December 2018 |
September 17, 2009 |
December 27, 2017 |
|
- Department of Medicine III, Division of Nephrology
Vienna, Austria
|
| 26 |
NCT02993146 |
Recruiting |
Ropidoxuridine and Whole Brain Radiation Therapy in Treating Patients With Brain Metastases |
- Metastatic Malignant Neoplasm
- Metastatic Malignant Neoplasm in the Brain
|
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Other: Quality-of-Life Assessment
- (and 2 more...)
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose of ropidoxuridine defined as the dose immediately below the lowest dose that produces dose limiting toxicities in at least 2 patients assessed by National Cancer Institute's Common Toxicity Criteria version 4
- Tumor response assessed by Response Evaluation Criteria in Solid Tumors 1.1
- Pharmacokinetic parameters of daily oral dosing of ropidoxuridine
- (and 4 more...)
|
47 |
All |
18 Years and older (Adult, Senior) |
NCT02993146 |
NCI-2016-01909
HP-00067789
9979
UM1CA186686 |
|
December 7, 2016 |
August 1, 2019 |
|
December 15, 2016 |
April 3, 2018 |
|
- UC San Diego Moores Cancer Center
La Jolla, California, United States - University of California Davis Comprehensive Cancer Center
Sacramento, California, United States - University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States - (and 4 more...)
|
| 27 |
NCT00369200 |
Terminated |
AFP464 in Treating Patients With Advanced Solid Tumors |
- Unspecified Adult Solid Tumor, Protocol Specific
|
- Drug: AFP464
- Other: laboratory biomarker analysis
- Other: pharmacological study
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose determined by dose-limiting toxicity
- Types and grades of toxicity
- Pharmacokinetic, pharmacodynamic, and pharmacogenomic parameters
- Response rate
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00369200 |
NCI-2009-00163
CDR0000492006
2006-011
7378
U01CA062487 |
|
June 2006 |
January 2011 |
|
August 29, 2006 |
December 11, 2013 |
|
- Wayne State University
Detroit, Michigan, United States
|
| 28 |
NCT02381561 |
Recruiting |
Ropidoxuridine in Treating Patients With Advanced Gastrointestinal Cancer Undergoing Radiation Therapy |
- Advanced Bile Duct Carcinoma
- Stage II Esophageal Cancer AJCC v7
- Stage II Pancreatic Cancer AJCC v6 and v7
- (and 38 more...)
|
- Radiation: Intensity-Modulated Radiation Therapy
- Other: Laboratory Biomarker Analysis
- Other: Pharmacological Study
- Drug: Ropidoxuridine
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose (MTD) defined as the dose below which 2 or more of 6 patients experience dose-limiting toxicity
- %iododeoxyuridine (IUdR)-deoxyribonucleic acid (DNA) incorporation in tumor biopsies
- Pharmacokinetic (PK) incorporation in tumor biopsies
- (and 3 more...)
|
30 |
All |
18 Years and older (Adult, Senior) |
NCT02381561 |
NCI-2015-00258
BRUOG 265
9882 |
|
February 1, 2016 |
August 1, 2018 |
|
March 6, 2015 |
March 5, 2018 |
|
- Rhode Island Hospital
Providence, Rhode Island, United States
|
| 29 |
NCT02859259 |
Completed |
A Study of the Relative Bioavailability of BMS-626529 Administered as BMS-663068 From 150mg Low-dose Extended-release Tablets Compared to 600mg Reference Extended-release Tablets in Healthy Subjects |
- Infection, Human Immunodeficiency Virus
|
- Drug: BMS-663068 (1 tablet at 600 mg)
- Drug: BMS-663068 (4 tablets at 150 mg each tablet)
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Bioavailability of BMS-626529 from low-dose ER tablet formulation of BMS-663068 relative to the reference ER tablet formulation.
- Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of electrocardiogram tests (ECGs), vital signs, physical exams, and clinical laboratory tests.
|
14 |
All |
18 Years to 50 Years (Adult) |
NCT02859259 |
206219
AI438-080 |
|
August 12, 2016 |
August 12, 2016 |
August 12, 2016 |
August 9, 2016 |
May 15, 2017 |
|
- GSK Investigational Site
Dallas, Texas, United States
|
| 30 |
NCT02598687 |
Withdrawn |
Testing TH-302, in Combination With Preoperative Chemoradiotherapy, in Esophageal Cancer. |
|
- Drug: TH-302
- Other: HX4 scan
- Drug: Carboplatin
- (and 3 more...)
|
Interventional |
Phase 1 |
- Maastricht Radiation Oncology
- Threshold Pharmaceuticals
- Zuyderland Medical Centre
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Dose Limiting Toxicity (DLT )
- hypoxia response in tumor
- rate of pathological Complete Remission (pCR)
- (and 6 more...)
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT02598687 |
14-27-03/09 |
|
December 2015 |
April 2016 |
April 2016 |
November 6, 2015 |
April 21, 2016 |
|
|
| 31 |
NCT00002677 |
Completed |
Tributyrin in Treating Patients With Refractory Prostate Cancer or Other Solid Tumors |
- Prostate Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
|
- Drug: chemotherapy
- Drug: tributyrin
|
Interventional |
Phase 1 |
- University of Maryland
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT00002677 |
UMCC-9421
CDR0000064322
NCI-T94-0181O |
|
August 1995 |
March 2003 |
March 2003 |
May 11, 2004 |
March 30, 2017 |
|
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States
|
| 32 |
NCT02173730 |
Completed |
BIBR 953 ZW in Healthy Elderly Subjects |
|
- Drug: BIBR 1048 MS
- Drug: Pantoprazole
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUCτ,ss (area under the plasma concentration time curve during a dosing interval at steady state)
- Cmax,ss (maximum measured concentration of the analyse in plasma at steady state over a uniform dosing interval τ)
- Aeτ,ss (amount of dose excreted in urine over one dosing interval at steady state)
- (and 12 more...)
|
36 |
All |
65 Years and older (Adult, Senior) |
NCT02173730 |
1160.10 |
|
November 2002 |
February 2003 |
|
June 25, 2014 |
June 25, 2014 |
|
|
| 33 |
NCT00435669 |
Completed |
A Phase I Study to Determine Absorption, Distribution, Metabolism, and Elimination of a Single Radiolabeled Dose of Brivanib (BMS-582664) |
|
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Absorption
- Distribution
- Metabolism
- (and 2 more...)
|
4 |
All |
18 Years and older (Adult, Senior) |
NCT00435669 |
CA182-008 |
|
September 2007 |
June 2008 |
June 2008 |
February 15, 2007 |
January 22, 2009 |
|
- Cleveland Clinic Foundation
Cleveland, Ohio, United States
|
| 34 |
NCT00348699 |
Completed |
AFP464 in Treating Patients With Metastatic or Refractory Solid Tumors That Cannot Be Removed By Surgery |
- Male Breast Cancer
- Recurrent Breast Cancer
- Recurrent Ovarian Epithelial Cancer
- (and 7 more...)
|
- Drug: AFP464
- Other: pharmacological study
- Other: laboratory biomarker analysis
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Maximum tolerated dose, overall toxicity incidence, and toxicity profiles of AFP464 in the treatment of solid tumors
- Overall response of AFP464 in the treatment of solid tumors
- Time to progression
- (and 4 more...)
|
68 |
All |
18 Years and older (Adult, Senior) |
NCT00348699 |
NCI-2009-00164
MAYO-IAB-05-00404800
MAYO-IAB-05-00404801
NCI-7380
CDR0000476275
MAYO-MC0513
MC0513
7380
P30CA015083
U01CA069912 |
|
July 2006 |
January 2013 |
|
July 6, 2006 |
February 24, 2014 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
| 35 |
NCT02508064 |
Completed |
Bioavailability of BMS-626529 in Healthy Subjects From Prototype Low Dose Extended Release Formulations (Part 1) and Prototype Extended Release Multi-particulate Formulations (Part 2) of BMS-663068 Relative to 600 mg Extended Release Tablet |
- Infection, Human Immunodeficiency Virus
|
|
Interventional |
Phase 1 |
- ViiV Healthcare
- GlaxoSmithKline
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Maximum observed concentration (Cmax) of BMS-626529
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-626529
- Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-626529
- (and 2 more...)
|
27 |
All |
18 Years to 50 Years (Adult) |
NCT02508064 |
206288
AI438-054 |
|
August 3, 2015 |
November 5, 2015 |
November 5, 2015 |
July 24, 2015 |
September 11, 2017 |
|
- GSK Investigational Site
Nottingham, United Kingdom
|
| 36 |
NCT01898416 |
Recruiting |
Safety and Efficacy Study Using 5-ALA Oral Administration as an Adjuvant Therapy on the Rate of Local Tumor Recurrence in Patients Who Have Desmoids Tumors |
- The Aim of the Study is to Evaluate the Efficacy of Photodynamic Therapy as an
- Adjuvant Therapy on the Clinical Outcome of Patients With Desmoid Tumors After
- Surgical Resection
|
- Drug: 5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.
|
Interventional |
Phase 2 |
- michal roll
- Tel-Aviv Sourasky Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary endpoint is a binary variable where each patient is classified as a recurrence or a not recurrence case and will be determined by calculating the proportion of recurrence versus non recurrence rates
- To assess the safety of study drug administration in the study population. To assess the 5 years local recurrence rate.
|
140 |
All |
18 Years and older (Adult, Senior) |
NCT01898416 |
TASMC-11-JB-558-CTIL |
|
June 2013 |
December 2023 |
December 2026 |
July 12, 2013 |
October 31, 2013 |
|
- Tel Aviv sourasky medical center
Tel AVIV, Israel - The Aviv Sourasky Medical Center
Tel Aviv, Israel
|
| 37 |
NCT01522872 |
Active, not recruiting |
Open-label Study of TH-302 and Dexamethasone With or Without Bortezomib or Pomalidomide in Subjects With Relapsed/Refractory Multiple Myeloma |
|
- Drug: TH-302
- Drug: TH-302 and Dexamethasone
- Drug: TH-302 Dose Escalation and Dexamethasone in Combination with Bortezomib
- Drug: TH-302 Dose Escalation and Dexamethasone in Combination with Pomalidomide
|
Interventional |
Phase 1
Phase 2 |
- Threshold Pharmaceuticals
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with adverse events (AEs)
- Type of adverse events(AEs)
- Severity of adverse events(AEs)
- (and 7 more...)
|
98 |
All |
18 Years and older (Adult, Senior) |
NCT01522872 |
TH-CR-408 |
|
February 2012 |
September 2016 |
September 2017 |
February 1, 2012 |
June 2, 2016 |
|
- Pacific Cancer Care
Monterey, California, United States - Moffitt Cancer Center
Tampa, Florida, United States - Maine Center for Cancer Medicine
Scarborough, Maine, United States - (and 7 more...)
|
| 38 |
NCT00655278 |
Terminated |
T2000 in Essential Tremor - Open Label Continuation |
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effect of treatment on tremor will be measured by a tremor scale as well as by assessment of functional activity with specific tasks.
- Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication.
|
5 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00655278 |
T2000-0639 |
|
August 2007 |
November 2009 |
December 2009 |
April 9, 2008 |
December 23, 2013 |
|
- Investigator Site
London, Ontario, Canada - Investigator Site
Ottawa, Ontario, Canada - Investigator Site
Toronto, Ontario, Canada
|
| 39 |
NCT00909766 |
Completed |
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects |
|
- Drug: BMS-830216
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests
- Pharmacokinetics: to assess the multiple-dose PK of BMS-830216
- Pharmacodynamics: to assess the pharmacodynamic effect of BMS-830216 on body weight and BMI over 4 weeks of therapy
|
113 |
All |
18 Years to 55 Years (Adult) |
NCT00909766 |
MB123-002 |
|
August 2009 |
June 2011 |
June 2011 |
May 28, 2009 |
November 4, 2015 |
|
- Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
|
| 40 |
NCT00506012 |
Terminated |
Pilot Efficacy Study of T2000 in Myoclonus Dystonia |
|
|
Interventional |
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Effect of treatment on the movement disorder will be measured by a myoclonus scale and a dystonia scale as well as by assessment of overall functional status. Response at various dosages will be compared to baseline for all patients.
- Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication.
|
5 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00506012 |
T2000-0633 |
|
August 2007 |
August 2011 |
October 2011 |
July 25, 2007 |
December 23, 2013 |
|
- Investigator Site
Toronto, Ontario, Canada
|
| 41 |
NCT00024986 |
Completed |
Tenofovir Disoproxil Fumarate to Treat Pediatric HIV |
|
|
Interventional |
Phase 1 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Primary Purpose: Treatment
|
|
30 |
All |
Child, Adult, Senior |
NCT00024986 |
020006
02-C-0006 |
|
October 2001 |
|
September 2005 |
October 11, 2001 |
March 4, 2008 |
|
- National Cancer Institute (NCI)
Bethesda, Maryland, United States
|
| 42 |
NCT00751270 |
Completed |
Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas |
- Malignant Glioma
- Glioblastoma Multiforme
- Anaplastic Astrocytoma
|
- Biological: AdV-tk
- Drug: Valacyclovir
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety of the intervention will be evaluated based on laboratory and clinical parameters graded using CTCAEver3.
- Tumor Response
- Progression-free Survival
- (and 2 more...)
|
15 |
All |
18 Years and older (Adult, Senior) |
NCT00751270 |
BrTK01 |
BrTK01 |
November 2005 |
January 2010 |
January 2011 |
September 11, 2008 |
March 4, 2016 |
|
- The Ohio State University Medical Center, Dept Neurosurgery
Columbus, Ohio, United States - The Methodist Hosptial
Houston, Texas, United States
|
| 43 |
NCT01057667 |
Completed |
A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4 |
|
- Drug: RO5024048
- Drug: Ribavirin [Copegus]
- Drug: peginterferon alfa-2a [Pegasys]
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)
- Virologic response over time
- Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin
- Resistance profile of RO5024048
|
168 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01057667 |
NV22621 |
|
February 2010 |
April 2012 |
April 2012 |
January 27, 2010 |
November 2, 2016 |
|
- La Jolla, California, United States
- Bradenton, Florida, United States
- Atlanta, Georgia, United States
- (and 22 more...)
|
| 44 |
NCT00321087 |
Terminated |
A Study of T2000 in Essential Tremor |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Effect of treatment on tremor will be measured by a tremor scale as well as by assessment of functional activity with specific tasks. Patients receiving active treatment will be compared to placebo at 2 months of treatment.
- Response at various dosages will be compared to baseline for all patients.
- Safety parameters including neurological examination, blood tests and EKG will be monitored throughout the treatment period and during withdrawal of the medication.
|
10 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT00321087 |
T2000-0533 |
|
August 2006 |
July 2007 |
December 2007 |
May 3, 2006 |
January 22, 2014 |
|
- Investigator Site
London, Ontario, Canada - Investigator Site
Ottawa, Ontario, Canada - Investigator Site
Toronto, Ontario, Canada
|
| 45 |
NCT00869661 |
Completed |
A Study of RO5024048 in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C, Genotype 1 or 4 |
|
- Drug: Copegus
- Drug: Pegasys
- Drug: RO5024048
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Sustained virologic response: Percentage of patients with undetectable Hepatitis C RNA level
- Virologic response: Percentage of patients with undetectable Hepatitis C RNA level
- Relapse rate: Percentage of patients who achieved a virologic response at the end of treatment but had detectable Hepatitis C RNA level at the last assessment post treatment
- Safety: Incidence of adverse events
|
413 |
All |
18 Years to 65 Years (Adult) |
NCT00869661 |
NV20536
2008-008258-21 |
|
February 2001 |
February 2012 |
February 2012 |
March 26, 2009 |
November 2, 2016 |
|
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Sacramento, California, United States
- (and 63 more...)
|
| 46 |
NCT01482403 |
Completed |
A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C |
|
- Drug: Copegus
- Drug: Pegasys
- Drug: boceprevir
- (and 3 more...)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Sustained virological response 12 weeks after treatment (SVR-12)
- Sustained virological response 4 weeks after treatment
- Virologic response over time
- (and 5 more...)
|
58 |
All |
18 Years and older (Adult, Senior) |
NCT01482403 |
NV27780
2011-002714-37 |
|
November 2011 |
January 2014 |
January 2014 |
November 30, 2011 |
August 5, 2016 |
|
- Littleton, Colorado, United States
- Chicago, Illinois, United States
- Shreveport, Louisiana, United States
- (and 21 more...)
|
| 47 |
NCT01482390 |
Completed |
A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C |
|
- Drug: Ribavirin
- Drug: Mericitabine
- Drug: Peginterferon Alfa-2a
- (and 2 more...)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test
- Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test
- Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test
- (and 7 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT01482390 |
NV27779
2011-002715-28 |
|
November 30, 2011 |
January 31, 2014 |
January 31, 2014 |
November 30, 2011 |
April 24, 2017 |
|
- Birmingham Gastro Associates, P.C.
Birmingham, Alabama, United States - VA Long Beach Healthcare System
Long Beach, California, United States - Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States - (and 36 more...)
|
| 48 |
NCT02170610 |
Completed |
Bioavailability of BIBR 1048 MS With and Without Pantoprazole Under Influence of Food in Healthy Subjects |
|
- Drug: BIBR 1048 MS
- Drug: Pantoprazole
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUC0-∞ (area under curve of BIBR 953 ZW in plasma over the time interval from 0 extrapolated to infinity) of BIBR 953 ZW
- AUC0-tf (area under the plasma concentration-time curve of BIBR 953 ZW over the time interval from 0 to the last quantifiable data point) of BIBR 953 ZW
- Cmax (maximum concentration of drug in plasma) of BIBR 953 ZW
- (and 5 more...)
|
18 |
Male |
18 Years to 55 Years (Adult) |
NCT02170610 |
1160.34 |
|
March 2002 |
May 2002 |
|
June 23, 2014 |
June 23, 2014 |
|
|
| 49 |
NCT02170597 |
Completed |
Bioavailability of BIBR 953 ZW Under Influence of Food in Healthy Subjects |
|
- Drug: BIBR 1048 MS HPMC capsule
- Drug: BIBR 1048 MS gelatine capsule
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- AUC0-∞ (area under the plasma concentration time curve from zero time extrapolated to infinity) of BIBR 953 ZW
- AUC0-tz (The area under the plasma concentration time curve from zero time to the time of the last quantifiable concentration) of BIBR 953 ZW
- Cmax (maximum measured concentration) of BIBR 953 ZW
- (and 5 more...)
|
12 |
Male |
18 Years to 55 Years (Adult) |
NCT02170597 |
1160.40 |
|
August 2003 |
September 2003 |
|
June 23, 2014 |
June 23, 2014 |
|
|
| 50 |
NCT02170623 |
Completed |
Bioavailability of BIBR 953 ZW After Administration of BIBR 1048 MS in Healthy Subjects |
|
- Drug: BIBR 1048 MS Capsule I
- Drug: BIBR 1048 MS Capsule K
- Drug: Pantoprazole
- Drug: BIBR 1048 MS drinking solution
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Total amount of BIBR 953 ZW excreted into urine during one dosing interval (Ae0-12)
- AUCss (Area under the plasma concentration-time curve at steady state) of BIBR 953 ZW
- Cmax,ss (maximum concentration at steady state) of BIBR 953 ZW
- tmax,ss (time from dosing to Cmax at steady state) of BIBR 953 ZW
|
12 |
Male |
18 Years to 55 Years (Adult) |
NCT02170623 |
1160.33 |
|
February 2002 |
April 2002 |
|
June 23, 2014 |
June 23, 2014 |
|
|
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