Status:
COMPLETED
A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
Lead Sponsor:
Celgene
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30
Exclusion
- 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).
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01474330
Start Date
August 1 2011
End Date
October 1 2011
Last Update
November 12 2019
Active Locations (1)
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1
PPD Phase I Clinic
Austin, Texas, United States, 78744