NCT04515628 is a Phase 1 clinical trial of Rosuvastatin in Healthy Participants, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT04515628?

NCT04515628 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT04515628?

Interventions in NCT04515628: Rosuvastatin, Branebrutinib.

What condition does NCT04515628 study?

NCT04515628 studies Healthy Participants.

Is NCT04515628 still recruiting?

NCT04515628 is currently completed. Last updated 10 March 2022.

Last reviewed 2022-03-10 · How we verify

NCT04515628

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

Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants

Completed Phase 1 Last updated 10 March 2022

What this trial tests

Phase 1 trial testing Rosuvastatin in Healthy Participants in 22 participants. Completed in 26 October 2020.

Timeline

2 August 2020

Primary endpoint
18 October 2020

26 October 2020

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	2 August 2020
Primary completion	18 October 2020
Estimated completion	26 October 2020
Sites	1 location across United States

Drugs / interventions tested

Rosuvastatin (rosuvastatin) — full drug profile →
Branebrutinib — full drug profile →

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents, rosuvastatin is also a likely concomitant drug for participants who would potentially be treated with branebrutinib.

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 Rosuvastatin

Trials testing the same drug.

NCT07474649 — A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events · Phase 3 · not yet recruiting
NCT07534592 — A Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants · Phase 1 · not yet recruiting
NCT07515339 — A Study to Learn More About How Safe Nurandociguat is and How it Affects the Way the Body Processes Rosuvastatin and Dab · Phase 1 · not yet recruiting
NCT07303816 — Statins to Prevent Cancer Associated Blood Clots · Phase 4 · not yet recruiting
NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting

Other recruiting trials for Healthy Participants

Currently open trials in the same condition.

NCT07469085 — A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Partici · Phase 1 · recruiting
NCT07503990 — Effects of Food Intake Sequence on Substrate Utilisation and Endurance Performance · NA · recruiting
NCT07474987 — Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury · recruiting
NCT07511205 — A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participa · Phase 1 · recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet 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 NCT04515628 (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 Bristol-Myers Squibb
Last refreshed: 10 March 2022

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/NCT04515628.

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