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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Pomalidomide

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Phase I Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Maria Palmisano, Celgene

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 17, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Actual): November 12, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Pomalidomide; tolerability; safety; pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Pomalidomide
• Other Study ID Numbers: CC-4047-CP-006