A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
- Registration Number
- NCT01474330
- Lead Sponsor
- Celgene
- Brief Summary
To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 33
Inclusion Criteria
Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30
Exclusion Criteria
- Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent Document (ICD), places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
- Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
- Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.5-mg Pomalidomide or placebo (Cohort A) Pomalidomide A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions 0.5-mg Pomalidomide or placebo (Cohort A) Placebo A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions 1-mg Pomalidomide or placebo (Cohort B) Placebo This arm may be initiated pending a safety review of Cohort A. A single 1-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. 2-mg Pomalidomide or placebo (Cohort C) Pomalidomide This arm may be initiated pending a safety review of Cohort B. A single 2-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. 2-mg Pomalidomide or placebo (Cohort C) Placebo This arm may be initiated pending a safety review of Cohort B. A single 2-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. 1-mg Pomalidomide or placebo (Cohort B) Pomalidomide This arm may be initiated pending a safety review of Cohort A. A single 1-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions.
- Primary Outcome Measures
Name Time Method area under the plasma concentration-time curve 72 hours after last dose area under the plasma concentration-time curve
Number of participants with adverse events 28 days after last dose Number of participants with adverse events
time to maximum observed plasma concentration 72 hours after last dose time to maximum observed plasma concentration
- Secondary Outcome Measures
Name Time Method maximum observed plasma concentration 72 hours after last dose maximum observed plasma concentration
terminal elimination half-life 72 hours after last dose terminal elimination half-life
apparent total plasma clearance 72 hours after last dose apparent total plasma clearance
apparent total volume of distribution, and accumulation ratio 72 hours after last dose apparent total volume of distribution, and accumulation ratio
Trial Locations
- Locations (1)
PPD Phase I Clinic
🇺🇸Austin, Texas, United States