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

NCT01474330 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-11-12

No results posted yet for this study

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

Interventions

DRUG

Pomalidomide

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

DRUG

Placebo

Placebo capsule

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Maria Palmisano · Celgene

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-01
Primary Completion
2011-10-01
Completion
2011-10-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474330 on ClinicalTrials.gov