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

NCT01474330 | Completed Phase 1

• 1 other identifier: CC-4047-CP-006
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Pomalidomide; safety; tolerability; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• maximum observed plasma concentration

  72 hours after last dose

• terminal elimination half-life

  72 hours after last dose

• apparent total plasma clearance

  72 hours after last dose

• apparent total volume of distribution, and accumulation ratio

  72 hours after last dose

Study Arms (3)

0.5-mg Pomalidomide or placebo (Cohort A)

EXPERIMENTAL

A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions

Drug: Pomalidomide; Drug: Placebo

1-mg Pomalidomide or placebo (Cohort B)

EXPERIMENTAL

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; Drug: Placebo

2-mg Pomalidomide or placebo (Cohort C)

EXPERIMENTAL

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; Drug: Placebo

Interventions

Pomalidomide DRUG

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

Also known as: CC-4047

0.5-mg Pomalidomide or placebo (Cohort A); 1-mg Pomalidomide or placebo (Cohort B); 2-mg Pomalidomide or placebo (Cohort C)

Placebo DRUG

Placebo capsule

0.5-mg Pomalidomide or placebo (Cohort A); 1-mg Pomalidomide or placebo (Cohort B); 2-mg Pomalidomide or placebo (Cohort C)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30

You may not qualify if:

• 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).

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

pomalidomide

Study Officials

• Maria Palmisano

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 18, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

US (1)