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

Celgene

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Pomalidomide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01474330

CC-4047-CP-006

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 3 patient groups

0.5-mg Pomalidomide or placebo (Cohort A)

Experimental group

Description:

A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions

Treatment:

Drug: Pomalidomide

Drug: Placebo

1-mg Pomalidomide or placebo (Cohort B)

Experimental group

Description:

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.

Treatment:

Drug: Pomalidomide

Drug: Placebo

2-mg Pomalidomide or placebo (Cohort C)

Experimental group

Description:

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.

Treatment:

Drug: Pomalidomide

Drug: Placebo