NCT06568458 is a Phase 1 clinical trial of Nintedanib in Healthy Participants, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT06568458?

NCT06568458 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT06568458?

Interventions in NCT06568458: Nintedanib, BMS 986278.

What condition does NCT06568458 study?

NCT06568458 studies Healthy Participants.

Is NCT06568458 still recruiting?

NCT06568458 is currently completed. Last updated 14 March 2025.

Last reviewed 2025-03-14 · How we verify

NCT06568458

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

A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants

Completed Phase 1 Last updated 14 March 2025

What this trial tests

Phase 1 trial testing Nintedanib in Healthy Participants in 71 participants. Completed in 27 February 2025.

Timeline

19 September 2024

Primary endpoint
27 February 2025

27 February 2025

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	71
Start date	19 September 2024
Primary completion	27 February 2025
Estimated completion	27 February 2025
Sites	1 location across United States

Drugs / interventions tested

Nintedanib (NINTEDANIB) — full drug profile →
BMS 986278

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Immune Checkpoint-Based Therapies in Colorectal Cancer-Current Approaches and Future Perspectives.
Nakielska K, Plewka J, Lenart M. · · 2026 · PMID 42196613 · DOI 10.3390/ijms27104628

Verify or expand the search:

Other trials of Nintedanib

Trials testing the same drug.

NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting
NCT07162961 — Nintedanib for Improving Reproductive Outcomes in Adenomyosis · Phase 3 · not yet recruiting
NCT06297096 — Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease · Phase 3 · recruiting
NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in · Phase 1 · completed
NCT06643091 — Nintedanib Treatment in Unicentric Castleman Disease · Phase 2 · not yet 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 NCT06568458 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 14 March 2025

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/NCT06568458.

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