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Completed

NCT Number: NCT04055506

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

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

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Key information

Conditions

Healthy Participants

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Salt Lake

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

  • 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

Treatment and study plan

BMS-986165

Drug

Dose 1

Ritonavir

Drug

100 mg

Primary outcomes

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

    Time frame: Day 1

  2. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165

    Time frame: Day 1

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165

    Time frame: Day 1

  4. Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir

    Time frame: Day 15

  5. 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

    Time frame: Day 15

  6. Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 in combination with steady-state ritonavir

    Time frame: Day 15

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: initial dose up to day 29

  2. vital signs of blood pressure

    Time frame: initial dose up to day 29

  3. Vital signs of body temperature

    Time frame: initial dose up to day 29

  4. Vital signs of respiratory rate

    Time frame: initial dose up to day 29

  5. Number of Clinically significant changes in lab assessment of blood serum

    Time frame: initial dose up to day 29

  6. Number of Clinically significant changes in the lab assessment of blood

    Time frame: initial dose up to day 29

  7. Number of Clinically significant changes in the lab assessment of urine

    Time frame: initial dose up to day 29

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 Induction by Ritonavir on the Pharmacokinetics of BMS-986165 in Healthy Participants

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2019
Registry last updated
Jun 18, 2020

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.

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