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Completed

NCT Number: NCT01474330

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pomalidomide

Drug

0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions

Other names: CC-4047

Placebo

Drug

Placebo capsule

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 28 days after last dose

    Number of participants with adverse events

  2. area under the plasma concentration-time curve

    Time frame: 72 hours after last dose

    area under the plasma concentration-time curve

  3. time to maximum observed plasma concentration

    Time frame: 72 hours after last dose

    time to maximum observed plasma concentration

Secondary outcomes

  1. maximum observed plasma concentration

    Time frame: 72 hours after last dose

    maximum observed plasma concentration

  2. terminal elimination half-life

    Time frame: 72 hours after last dose

    terminal elimination half-life

  3. apparent total plasma clearance

    Time frame: 72 hours after last dose

    apparent total plasma clearance

  4. apparent total volume of distribution, and accumulation ratio

    Time frame: 72 hours after last dose

    apparent total volume of distribution, and accumulation ratio

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 18, 2011
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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