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

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT01474330
Collaborator
(none)
33
Enrollment
1
Location
3
Arms
2
Actual Duration (Months)
16.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
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
Actual Study Start Date :
Aug 1, 2011
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

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: Pomalidomide
0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
Other Names:
  • 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 Names:
  • 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 Names:
  • CC-4047

    • Drug: Placebo
    Placebo capsule

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events [28 days after last dose]

      Number of participants with adverse events

    2. area under the plasma concentration-time curve [72 hours after last dose]

      area under the plasma concentration-time curve

    3. time to maximum observed plasma concentration [72 hours after last dose]

      time to maximum observed plasma concentration

    Secondary Outcome Measures

    1. maximum observed plasma concentration [72 hours after last dose]

      maximum observed plasma concentration

    2. terminal elimination half-life [72 hours after last dose]

      terminal elimination half-life

    3. apparent total plasma clearance [72 hours after last dose]

      apparent total plasma clearance

    4. apparent total volume of distribution, and accumulation ratio [72 hours after last dose]

      apparent total volume of distribution, and accumulation ratio

    Eligibility Criteria

    Criteria

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

    Locations

    Site City State Country Postal Code
    1 PPD Phase I Clinic Austin Texas United States 78744

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Maria Palmisano, Celgene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT01474330
    Other Study ID Numbers:
    • CC-4047-CP-006
    First Posted:
    Nov 18, 2011
    Last Update Posted:
    Nov 12, 2019
    Last Verified:
    Nov 1, 2019
    Keywords provided by Celgene
    Pomalidomide
    safety
    tolerability
    pharmacokinetics
    Additional relevant MeSH terms:
    Pomalidomide

    Study Results

    No Results Posted as of Nov 12, 2019