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Completed

NCT Number: NCT04671953

Effect of BMS-986165 on the Blood Levels of Metformin

The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin 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 - 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

  • Healthy, as determined by having no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory determinations
  • Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
  • Must agree to follow specific methods of contraception, if applicable

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 or active liver disease

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986165

Drug

Specified dose on specified days

Other names: Deucravacitinib

metformin

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165

    Time frame: Up to 9 days

  2. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) in plasma for metformin with and without BMS-986165

    Time frame: Up to 9 days

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

    Time frame: Up to 9 days

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 13 days

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 71 days

  3. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 41 days

  4. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 41 days

  5. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 41 days

  6. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 41 days

  7. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval

    Time frame: Up to 41 days

    PR interval is the time from the onset of the P wave to the start of the QRS complex

  8. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS

    Time frame: Up to 41 days

    QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization

  9. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval

    Time frame: Up to 41 days

    The QT interval is the time from the start of the Q wave to the end of the T wave

  10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF

    Time frame: Up to 41 days

    QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave

  11. Incidence of clinically significant changes in clinical laboratory values: Hematology tests

    Time frame: Up to 41 days

  12. Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests

    Time frame: Up to 41 days

  13. Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests

    Time frame: Up to 41 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Two-arm Crossover Study to Investigate the Effect of BMS-986165 on the Pharmacokinetics of Metformin in Healthy Volunteers

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
Nov 11, 2021

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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