A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04055506

Enrollment

Registered

2019-08-13

Start date

2019-08-14

Completion date

2019-09-21

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Brief summary

The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in Healthy Participants

Interventions

DRUGBMS-986165

Dose 1

DRUGRitonavir

100 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.732 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula. * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic onadotropin) within 24 hours prior to the start of study treatment. * Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening.

Exclusion criteria

* Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1. * Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population. * Prisoners or participants who are involuntarily incarcerated * Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease

Design outcomes

Primary

Measure	Time frame
Maximum observed plasma concentration (Cmax) of BMS-986165	Day 1
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165	Day 1
Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165	Day 1
Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir	Day 15
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 in combination with steady-state ritonavir	Day 15
Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 in combination with steady-state ritonavir	Day 15

Secondary

Measure	Time frame
Incidence of Adverse Events (AEs)	initial dose up to day 29
Number of Clinically significant changes in the lab assessment of urine	initial dose up to day 29
vital signs of blood pressure	initial dose up to day 29
Vital signs of body temperature	initial dose up to day 29
Vital signs of respiratory rate	initial dose up to day 29
Number of Clinically significant changes in lab assessment of blood serum	initial dose up to day 29
Number of Clinically significant changes in the lab assessment of blood	initial dose up to day 29

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026