NCT05932303

Brief Summary

This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

July 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2023

Completed
Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

June 27, 2023

Last Update Submit

October 26, 2023

Conditions

Healthy Participants

Keywords

BMS-986278ItraconazoleGemfibrozilCarbamazepineIdiopathic pulmonary fibrosisDrug interaction

Outcome Measures

Primary Outcomes (3)

  • Maximum observed plasma concentration (Cmax)

    Up to 33 days

  • Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])

    Up to 33 days

  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

    Up to 33 days

Secondary Outcomes (5)

  • Number of participants with adverse events (AEs)

    Up to 33 days

  • Number of participants with physical examination abnormalities

    Up to 33 days

  • Number of participants with vital sign abnormalities

    Up to 33 days

  • Number of participants with electrocardiogram (ECG) abnormalities

    Up to 33 days

  • Number of participants with clinical laboratory abnormalities

    Up to 33 days

Study Arms (3)

BMS-986278, followed by itraconazole

EXPERIMENTAL
Drug: BMS-986278Drug: Itraconazole

BMS-986278, followed by gemfibrozil

EXPERIMENTAL
Drug: BMS-986278Drug: Gemfibrozil

BMS-986278, followed by carbamazepine

EXPERIMENTAL
Drug: BMS-986278Drug: Carbamazepine

Interventions

BMS-986278DRUG

Specified dose on specified days

BMS-986278, followed by carbamazepineBMS-986278, followed by gemfibrozilBMS-986278, followed by itraconazole
ItraconazoleDRUG

Specified dose on specified days

BMS-986278, followed by itraconazole
GemfibrozilDRUG

Specified dose on specified days

BMS-986278, followed by gemfibrozil
CarbamazepineDRUG

Specified dose on specified days

BMS-986278, followed by carbamazepine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m\^2) through 32.0 kg/m\^2, inclusive.
  • BMI = weight (kg)/(height \[m\])2.
  • Body weight ≥ 50 kg for males and ≥ 45 kg for females.

You may not qualify if:

  • Any significant acute or chronic medical illness.
  • Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.
  • Any major surgery within 4 weeks of study intervention administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Québec, CA, G1P 0A2, Canada

Location

Related Links

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

ItraconazoleGemfibrozilCarbamazepine

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesFibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPentanoic AcidsValeratesPhenyl EthersEthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsFatty Acids, VolatileFatty AcidsLipidsDibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

July 12, 2023

Primary Completion

October 23, 2023

Study Completion

October 23, 2023

Last Updated

October 30, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/ disclosure-commitment.html

Locations

CA(1)