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

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

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986165
* Drug: Ritonavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination Therapy<br> | Drug: BMS-986165<br>* Dose 1<br>Drug: Ritonavir<br>* 100 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | 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 | 
| Number of Clinically significant changes in the lab assessment of urine |  | initial dose up to day 29 |