A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01474330

Run by

Celgene

People needed

33

Starts

2011-08-01

Expected to finish

2011-10-01

Last updated by the study team

2019-11-12

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30

You may not qualify if…

• 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).

Where it is running

• PPD Phase I Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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