CG400549 Single Ascending Dose Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CrystalGenomics, Inc.
ClinicalTrials.gov Identifier:
NCT01085578
First received: March 10, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

Evaluation of Safety, Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers


Condition Intervention Phase
Healthy
Drug: CG400549/placebo
Drug: CG400549
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Safety,Tolerability and Pharmacokinetic Characteristics of CG400549 in Healthy Volunteers

Further study details as provided by CrystalGenomics, Inc.:

Primary Outcome Measures:
  • safety [ Time Frame: 1month ] [ Designated as safety issue: Yes ]
    AEs, vital signs, clinical laboratory, 12-lead ECG; physical examination


Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 1month ] [ Designated as safety issue: No ]
    plasma and urine CG400549 concentrations; PK parameters Cmax, tmax, kel, t1/2,z, AUC0-last, AUC0-inf, %AUC, CL/F, Vd/F, MRT and Ae


Enrollment: 18
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Cohort1
CG400549/placebo
Drug: CG400549/placebo
Period 1: a single oral dose of 80 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 320 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1280 mg CG400549 or placebo on Day 1
Other Name: Cohort 1
Placebo Comparator: Cohort2
CG400549/placebo
Drug: CG400549/placebo
Period 1: a single oral dose of 160 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 640 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1920 mg CG400549 or placebo on Day 1
Other Name: Cohort 2
Cohort3
CG400549
Drug: CG400549
Period 1: a single oral dose of 640 mg CG400549 on Day 1 in the fasted state Period 2: a single oral dose of 640 mg CG400549 on Day 1 in the fed state
Other Name: Cohort 3

Detailed Description:

This was a Phase 1, 2-part study consisting of a randomized, double-blind, placebo-controlled,single ascending dose (SAD) part (in 2 alternating panels) and a 1-sequence food effect (FE) part. In the SAD part, 2 cohorts of 6 healthy male subjects each received a single oral dose of CG400549 or placebo in 3 periods, randomized such that each subject received active treatment twice and placebo once (in each period, 4 subjects received active drug and 2 received placebo). In the FE part, 1 cohort of 6 healthy male subjects received a single oral dose of CG400549 in the fasted state in Period 1 and a single oral dose of CG400549 in the fed state in Period 2.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Sex : male
  • 2. Age : 18-55 years, inclusive
  • 3. BMI : 19-30 kg/m2
  • 4. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research centre until discharge
  • 5. Medical history without major pathology
  • 6. Normal blood pressure (systolic 90-140 mmHg; diastolic 60-90 mmHg) and heart rate (45 90 beats per minute); minor deviations from these criteria could be accepted if considered to be clinically insignificant by the Medical Investigator
  • 7. Computerised (12-lead) ECG recording normal or showing no clinically relevant deviations as judged by the Medical Investigator
  • 8. Male subjects and their female sexual partners must use double-barrier contraception during the study period and for 90 days after follow-up
  • 9. All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the Medical Investigator. In particular, liver enzymes (aspartate aminotransferase [ASAT] and alanine aminotransferase [ALAT]) must be within the normal range and creatine phosphokinase (CPK) must be within 2.0 times the normal range.
  • 10. Willingness to sign the written Informed Consent Form (ICF)

Exclusion Criteria:

  • 1. Evidence of clinically relevant pathology
  • 2. History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
  • 3. Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.
  • 4. Family history of significant cardiac disease (e.g., sudden cardiac death or myocardial infarction prior to age 50 in a first-degree relative)
  • 5. Mental handicap, relevant cognitive or psychiatric disorders or history of seizures
  • 6. History and/or presence of relevant drug and/or food allergies
  • 7. Use of concomitant medication, except for acetaminophen (paracetamol), which is allowed up to 3 days before entrance into the research facility. All other medication (including over-the-counter medication, health supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to the first dose. The use of a limited amount of acetaminophen (≤ 2 g/day) is permitted.
  • 8. Participation in a drug study within 60 days prior to drug administration. Participation in more than 3 other drug studies in the 10 months preceding the start of this study.
  • 9. Donation of more than 50 mL of blood (whole blood or blood component) within 60 days prior to drug administration.
  • 10. History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
  • 11. Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol
  • 12. Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
  • 13. Positive screen on hepatitis B surface antigen (HBsAg)
  • 14. Positive screen on anti hepatitis C virus (HCV)
  • 15. Positive screen on anti human immunodeficiency virus 1 and 2 (HIV 1/2)
  • 16. Illness within 5 days prior to drug administration
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085578

Locations
Netherlands
PRA International clinical center
Zuidlaren, Netherlands
Sponsors and Collaborators
CrystalGenomics, Inc.
Investigators
Study Chair: Seonggu Ro, PhD CrystalGenomics, Inc.
  More Information

No publications provided

Responsible Party: CrystalGenomics, Inc.
ClinicalTrials.gov Identifier: NCT01085578     History of Changes
Other Study ID Numbers: CG400549-1-01
Study First Received: March 10, 2010
Last Updated: February 13, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by CrystalGenomics, Inc.:
healthy male volunteers
fasted and fed state

ClinicalTrials.gov processed this record on July 31, 2014