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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pomalidomide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.5-mg Pomalidomide or placebo (Cohort A)<br>A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions | Drug: Pomalidomide<br>* 0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions<br>* Other names: CC-4047;Drug: Placebo<br>* Placebo capsule<br>|
| Experimental: 1-mg Pomalidomide or placebo (Cohort B)<br>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. | Drug: Pomalidomide<br>* 0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions<br>* Other names: CC-4047;Drug: Placebo<br>* Placebo capsule<br>|
| Experimental: 2-mg Pomalidomide or placebo (Cohort C)<br>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. | Drug: Pomalidomide<br>* 0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions<br>* Other names: CC-4047;Drug: Placebo<br>* Placebo capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Number of participants with adverse events | 28 days after last dose | 
| area under the plasma concentration-time curve | area under the plasma concentration-time curve | 72 hours after last dose | 
| time to maximum observed plasma concentration | time to maximum observed plasma concentration | 72 hours after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum observed plasma concentration | maximum observed plasma concentration | 72 hours after last dose | 
| terminal elimination half-life | terminal elimination half-life | 72 hours after last dose | 
| apparent total plasma clearance | apparent total plasma clearance | 72 hours after last dose | 
| apparent total volume of distribution, and accumulation ratio | apparent total volume of distribution, and accumulation ratio | 72 hours after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pomalidomide, safety, tolerability, pharmacokinetics