NCT01835561 is a Phase 1 clinical trial of Pomalidomide in Clinical Pharmacology, Healthy Volunteer Study, sponsored by Celgene.

Who is sponsoring NCT01835561?

NCT01835561 is sponsored by Celgene.

What drugs are being tested in NCT01835561?

Interventions in NCT01835561: Pomalidomide, Pomalidomide.

What condition does NCT01835561 study?

NCT01835561 studies Clinical Pharmacology, Healthy Volunteer Study.

Is NCT01835561 still recruiting?

NCT01835561 is currently completed. Last updated 12 November 2019.

Last reviewed 2019-11-12 · How we verify

NCT01835561

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study to Evaluate Pharmacokinetics of Pomalidomide in Hepatically Impaired Males

Completed Phase 1 Last updated 12 November 2019

What this trial tests

Phase 1 trial testing Pomalidomide in Clinical Pharmacology, Healthy Volunteer Study in 32 participants. Completed in 21 August 2014.

Timeline

1 March 2013

Primary endpoint
16 August 2014

21 August 2014

Quick facts

Lead sponsor	Celgene
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	32
Start date	1 March 2013
Primary completion	16 August 2014
Estimated completion	21 August 2014
Sites	2 locations across United States

Drugs / interventions tested

Pomalidomide — full drug profile →
Pomalidomide — full drug profile →

Conditions studied

Clinical Pharmacology, Healthy Volunteer Study — all drugs for Clinical Pharmacology, Healthy Volunteer Study →

Sponsor

Celgene — full company profile →

Who can join

Adults 18 to 70, male only, with Clinical Pharmacology, Healthy Volunteer Study. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Pomalidomide

Trials testing the same drug.

NCT07463807 — Testing the Investigational Medication Combination of Teclistamab and Pomalidomide Compared to the Usual Treatment (Carf · Phase 1, PHASE2 · not yet recruiting
NCT06948084 — Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Darat · Phase 2 · not yet recruiting
NCT07523737 — Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed/Refractory Primary Central Nervous System Dif · Phase 2 · recruiting
NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi · Phase 3 · recruiting
NCT07096778 — Inobrodib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting

Other Celgene trials

Trials by the same sponsor.

NCT07242781 — A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult M · Phase 1 · recruiting
NCT06988488 — A Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide · Phase 1, PHASE2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT06808984 — Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants W · Phase 2 · recruiting
NCT06782490 — A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spastici · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01835561 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 12 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01835561.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing