Healthy
Conditions
Keywords
Pomalidomide, safety, tolerability, pharmacokinetics
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.
Interventions
DRUGPomalidomide
0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
DRUGPlacebo
Placebo capsule
Sponsors
Celgene
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
1. 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. 2. 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. 3. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to maximum observed plasma concentration | 72 hours after last dose | time to maximum observed plasma concentration |
| Number of participants with adverse events | 28 days after last dose | Number of participants with adverse events |
| area under the plasma concentration-time curve | 72 hours after last dose | area under the plasma concentration-time curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximum observed plasma concentration | 72 hours after last dose | maximum observed plasma concentration |
| apparent total volume of distribution, and accumulation ratio | 72 hours after last dose | apparent total volume of distribution, and accumulation ratio |
| 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 |
Countries
United States
Outcome results
None listed