Skip to main content
OpenTrials
Completed

NCT Number: NCT03930602

Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Plc (PRA Health Sciences)

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
  • Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
  • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion criteria

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
  • Any major surgery within 4 weeks of study drug administration
  • Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.

Treatment and study plan

BMS-986165

Drug

Participants will receive BMS-986165.

Fluvoxamine

Drug

Participants will receive fluvoxamine.

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986165

    Time frame: 10 days

  2. AUC(0-T) of BMS-986165

    Time frame: 10 days

  3. AUC(INF) of BMS-986165

    Time frame: 10 days

Secondary outcomes

  1. Fluvoxamine steady-state plasma concentrations

    Time frame: 10 days

  2. Percentage of participants with Adverse events (AEs)

    Time frame: From screening up to end of drug treatment (Day 13)

  3. Percentage of participants with Serious Adverse events (SAEs) and Death

    Time frame: From screening up to end of drug treatment (Day 13)

  4. Percentage of participants with Adverse events (AEs) leading to discontinutation

    Time frame: From screening up to end of drug treatment (Day 13)

  5. Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs

    Time frame: From screening up to end of drug treatment (Day 13)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.