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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-01

Study Completion Date

2011-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 1 QT Study in Healthy Male Subjects

NCT01986894

Clinical Pharmacology, Healthy Volunteer Study

COMPLETED PHASE1

MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma

NCT00833833

Multiple Myeloma

COMPLETED PHASE1/PHASE2

A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma

NCT00424047

Multiple Myeloma

COMPLETED PHASE3

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma

NCT01745588

Multiple Myeloma

COMPLETED PHASE2

Pomalidomide for Myelofibrosis Patients

NCT00946270

Polycythemia Vera Thrombocythemia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Pomalidomide

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo capsule

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.

Group Type EXPERIMENTAL

Pomalidomide

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo capsule

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.

Group Type EXPERIMENTAL

Pomalidomide

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pomalidomide

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

Intervention Type DRUG

Placebo

Placebo capsule

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CC-4047

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes