Effect of BMS-986165 on the Blood Levels of Metformin

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986165; Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA Health Sciences - Lenexa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: BMS-986165 Dose 1 + Metformin	Drug: BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib; Drug: Metformin; Specified dose on specified days
Experimental: Arm 2: BMS-986165 Dose 2 + Metformin	Drug: BMS-986165; Specified dose on specified days; Other Names: Deucravacitinib; Drug: Metformin; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165	Up to 9 days
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	Up to 9 days
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	Up to 9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically significant changes in vital signs: Body temperature		Up to 41 days
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 41 days
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 41 days
Incidence of clinically significant changes in vital signs: Heart rate		Up to 41 days
Incidence of adverse events (AEs)		Up to 13 days
Incidence of serious adverse events (SAEs)		Up to 71 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to 41 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to 41 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave	Up to 41 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF	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	Up to 41 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Up to 41 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests		Up to 41 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests		Up to 41 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): March 3, 2021
• Study Completion (Actual): March 30, 2021

Study Registration Dates

• First Submitted: December 15, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 9, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Metformin; Pharmacodynamics; Drug interaction
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Dermatologic Agents; Protein Kinase Inhibitors; Metformin; BMS-986165
• Other Study ID Numbers: IM011-159

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No