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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01474330
First received: November 16, 2011
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Pomalidomide
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 28 days after last dose ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • area under the plasma concentration-time curve [ Time Frame: 72 hours after last dose ] [ Designated as safety issue: No ]
    area under the plasma concentration-time curve

  • time to maximum observed plasma concentration [ Time Frame: 72 hours after last dose ] [ Designated as safety issue: No ]
    time to maximum observed plasma concentration


Secondary Outcome Measures:
  • maximum observed plasma concentration [ Time Frame: 72 hours after last dose ] [ Designated as safety issue: No ]
    maximum observed plasma concentration

  • terminal elimination half-life [ Time Frame: 72 hours after last dose ] [ Designated as safety issue: No ]
    terminal elimination half-life

  • apparent total plasma clearance [ Time Frame: 72 hours after last dose ] [ Designated as safety issue: No ]
    apparent total plasma clearance

  • apparent total volume of distribution, and accumulation ratio [ Time Frame: 72 hours after last dose ] [ Designated as safety issue: No ]
    apparent total volume of distribution, and accumulation ratio


Enrollment: 33
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Pomalidomide
0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
Other Name: CC-4047
Drug: Placebo
Placebo capsule
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: Pomalidomide
0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
Other Name: CC-4047
Drug: Placebo
Placebo capsule
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: Pomalidomide
0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
Other Name: CC-4047
Drug: Placebo
Placebo capsule

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474330

Locations
United States, Texas
PPD Phase I Clinic
Austin, Texas, United States, 78744
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Maria Palmisano Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01474330     History of Changes
Other Study ID Numbers: CC-4047-CP-006
Study First Received: November 16, 2011
Last Updated: October 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Celgene Corporation:
Pomalidomide
safety
tolerability
pharmacokinetics

Additional relevant MeSH terms:
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014