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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

November 16, 2011
October 16, 2012
August 2011
October 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01474330 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Healthy
  • 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: 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
    Interventions:
    • Drug: Pomalidomide
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Pomalidomide
    • Drug: Placebo
  • 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.
    Interventions:
    • Drug: Pomalidomide
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
October 2011
October 2011   (final data collection date for primary outcome measure)

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).
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01474330
CC-4047-CP-006
No
Celgene Corporation
Celgene Corporation
Not Provided
Study Director: Maria Palmisano Celgene Corporation
Celgene Corporation
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP