Clinical trial NCT04055506: A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-08-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986165
timeFrame: Day 1
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165
timeFrame: Day 1
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165
timeFrame: Day 1
measure: Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir
timeFrame: Day 15
measure: 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
timeFrame: Day 15
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 in combination with steady-state ritonavir
timeFrame: Day 15
Secondary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: initial dose up to day 29
measure: vital signs of blood pressure
timeFrame: initial dose up to day 29
measure: Vital signs of body temperature
timeFrame: initial dose up to day 29
measure: Vital signs of respiratory rate
timeFrame: initial dose up to day 29
measure: Number of Clinically significant changes in lab assessment of blood serum
timeFrame: initial dose up to day 29
measure: Number of Clinically significant changes in the lab assessment of blood
timeFrame: initial dose up to day 29
measure: Number of Clinically significant changes in the lab assessment of urine
timeFrame: initial dose up to day 29
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences - Salt Lake
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: