Effect of BMS-986165 on the Blood Levels of Metformin

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671953
• Other study ID #: IM011-159
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: November 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 30, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986165
Specified dose on specified days
• Metformin
Specified dose on specified days

Locations

Country	Name	City	State
United States	PRA Health Sciences - Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165		Up to 9 days
Primary	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
Primary	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	Incidence of adverse events (AEs)		Up to 13 days
Secondary	Incidence of serious adverse events (SAEs)		Up to 71 days
Secondary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 41 days
Secondary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 41 days
Secondary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 41 days
Secondary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 41 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Up to 41 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests		Up to 41 days
Secondary	Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests		Up to 41 days

External Links

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