A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
| End Date: | October 2011 |
A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) Following Multiple Daily Doses in Healthy Male Subjects
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.
orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
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).
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