Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 69 of 69 for:    Famotidine

A Phase 1 Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01841489
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This is a Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Treatment A Drug: Treatment B Drug: Treatment C Drug: Treatment D Drug: Treatment E Drug: Treatment F Drug: Treatment G Drug: Treatment H Drug: Treatment I Drug: Treatment J Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Adaptive Study of Novel GS-9973 Tablet Formulations to Evaluate the Effect of Acid Reducing Agents, Relative Bioavailability, and Food Effect on GS-9973 Pharmacokinetics
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : October 2013


Arm Intervention/treatment
Experimental: Sequence 1 Drug: Treatment A
1600 mg GS-9973 (Formulation 1)

Drug: Treatment B
1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole

Drug: Treatment G
1600 mg GS-9973 (Reference formulation)

Drug: Treatment I
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily

Experimental: Sequence 2 Drug: Treatment A
1600 mg GS-9973 (Formulation 1)

Drug: Treatment C
1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine

Drug: Treatment H
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)

Drug: Treatment J
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily

Experimental: Sequence 3 Drug: Treatment D
1600 mg GS-9973 (Formulation 2)

Drug: Treatment E
1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole

Drug: Treatment G
1600 mg GS-9973 (Reference formulation)

Drug: Treatment I
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily

Experimental: Sequence 4 Drug: Treatment D
1600 mg GS-9973 (Formulation 2)

Drug: Treatment F
1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine

Drug: Treatment H
1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)

Drug: Treatment J
An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily




Primary Outcome Measures :
  1. Pharmacokinetic parameters for GS-9973 [ Time Frame: Up to 3 months ]
    The primary outcome measure is the pharmacokinetic (PK) parameters for GS-9973 including AUC and Cmax.


Secondary Outcome Measures :
  1. Secondary pharmacokinetic parameters for GS-9973 [ Time Frame: Up to 3 months ]
    A secondary outcome measure is the pharmacokinetic parameters for GS-9973 including Ctau and AUClast.

  2. Incidence of Adverse Events [ Time Frame: Up to 3 months ]
    A secondary outcome measure is the safety and tolerability of GS-9973 which will be evaluated by the incidence of AEs including assessment of clinical laboratory test findings, physical examinations, 12-lead ECG abnormalities, and vital signs measurements.

  3. Blood PD parameters for GS-9973 [ Time Frame: Up to 3 months ]
    A secondary outcome measure is the blood pharmacodynamic parameters.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Must have a body mass index (BMI) range of approximately 19 to 30 kg/m2
  • Must have a minimum weight of 45 kg
  • Females of childbearing potential must have negative serum pregnancy tests at screening and baseline and must practice at least 1 reliable method of contraception as defined by the protocol

    • Female subjects who utilize hormonal contraceptive as 1 of their birth control methods must have used the same method for at least 3 months prior to study dosing
  • Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation from Day -1 until 90 days following the last dose of study medication
  • Must refrain from blood donation throughout the study period
  • Must, in the opinion of the Investigator, be in good general
  • Must be a non- or light smoker, eg, less than 10 cigarettes per day

Exclusion Criteria:

  • Pregnant or lactating subjects
  • Use of prescribed or over-the-counter medications that affect gastric pH
  • History of severe peptic ulcer disease, GERD, or other diseases requiring prolonged(>6 weeks) medication or surgical therapy to modify gastric pH
  • Have a history of clinically significant cardiac abnormalities or presence of clinically significant abnormality on 12-lead ECG.
  • Have a history of any cancer requiring systemic chemotherapy or radiation
  • Have a history of bleeding disorders
  • Have a history of liver disorders
  • Current acute infection or history of acute infection within 7 days
  • Have a recent history of alcohol or illicit drug abuse and/or have a positive test for selected drugs of abuse
  • Have a positive hepatitis screen or positive Human Immunodeficiency Virus antibody test
  • Have participated in another clinical trial within 28 days
  • Have received transfusion of blood or plasma products within 6 months
  • Have donated > 500 mL blood within 56 days
  • Are unable or unwilling to comply with study restrictions, return for follow-up appointments, or other considerations, which in the opinion of the Investigator, would make the candidate unsuitable for study participation
  • Current or historical medical condition that is deemed to be of medical significance by the Investigator
  • Have used prescription medications, over the counter products, herbal remedies and nutritional supplements within 7 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841489


Locations
Layout table for location information
United States, Florida
Investigational Site
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Michael Hawkins, MD Gilead Sciences

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01841489     History of Changes
Other Study ID Numbers: GS-US-339-0111
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

Keywords provided by Gilead Sciences:
Chronic Lymphocytic Leukemia
CLL

Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell