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Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males

NCT01835561 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-11-12

No results posted yet for this study

Summary

This study is for research purposes only and will not treat any disease or condition you may have. The study is an open label and single dose study; open label means that you, the study doctor and study staff will know which study drug you are taking.

The purpose of this research study is to compare drug levels in the body of people with liver disease to drug levels in healthy people with a normal liver. In addition, the safety of the study drug will be studied. Information about any side effects (discomfort or decline in health) that may happen will be collected. The study drug will be given by mouth to subjects with liver disease and to healthy subjects.

In the body, drugs are normally removed by the liver with a smaller amount being removed by the kidneys. When the liver is not working as well as it should, the body may not be able to remove drugs from the body quickly.

The information from this study will be used to decide if the drug is safe in subjects with liver disease or if a lower dose of the study drug would be safer.

Conditions

  • Clinical Pharmacology, Healthy Volunteer Study

Interventions

DRUG

Pomalidomide

Single oral dose of 4-mg capsule

DRUG

Pomalidomide

4-mg capsule

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Edward O'Mara, MD · Celgene Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-03-01
Primary Completion
2014-08-16
Completion
2014-08-21

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 NCT01835561 on ClinicalTrials.gov