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OpenTrials
Completed

NCT Number: NCT04113668

The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants

BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Lenexa

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

  • Women and men must agree to follow instructions for methods of contraception.
  • Participants must be willing and able to complete all study-specific procedures and visits.
  • A healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
  • WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.

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, including a history of active liver disease
  • History of biliary disorders, including Gilbert's syndrome or Dubin- Johnson disease, in addition to, current or recent gastrointestinal disease that could impact the absorption of study drug.
  • Participants using electronic cigarettes or nicotine-containing products who have stopped smoking less than 6 months prior to dosing on Day 1.
  • Consumption of chargrilled meat, quinine, or any nutrient known to modulate CYP enzyme activity within 14 days prior to first administration of study treatment.
  • History of any significant drug allergy

Other inclusion/exclusion criteria apply

Treatment and study plan

BMS-986165

Drug

Specified Dose on Specified Days

diflunisal

Drug

Specified Dose on Specified Days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor

    Time frame: Up to 14 days

  2. Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor

    Time frame: up to 14 days

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor

    Time frame: up to 14 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: up to 48 days

  2. Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities

    Time frame: up to 48 days

  3. Physical Examination of weight

    Time frame: up to 48 days

  4. Number of changes in blood pressure

    Time frame: up to 20 days

  5. Number of changes in body temperature

    Time frame: up to 20 days

  6. Number of changes in respiratory rate

    Time frame: up to 20 days

  7. Number of clinical significant changes in lab assessment of blood serum

    Time frame: up to 48 days

  8. Number of Clinically significant changes in assessment of blood

    Time frame: up to 20 days

  9. Number of Clinically significant changes in lab assessment of urine

    Time frame: up to 20 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

AN OPEN-LABEL, SINGLE-SEQUENCE, CROSSOVER STUDY TO INVESTIGATE THE EFFECTS OF UGT1A9 INHIBITOR DIFLUNISAL, AT STEADY-STATE, ON PHARMACOKINETICS OF A SINGLE DOSE OF BMS-986165 IN HEALTHY MALE AND FEMALE VOLUNTEERS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2019
Registry last updated
Aug 5, 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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