An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

Healthy Participants Clinical Trial

Official title:

An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660436
• Other study ID #: IM011-071
• Status: Completed
• Phase: Phase 1
• Start date: August 14, 2018
• Est. completion date: October 18, 2018

Study information

• Verified date: December 2018
• 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 experimental medication BMS-986165 in healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: October 18, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• 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 participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations

• Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight = 50 kg, at screening

• Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2

Exclusion Criteria:

• Any 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

• Positive anti- John Cunningham virus (JCV) antibody test at Screening

• History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

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 plasma concentration (Cmax) of mycophenolic acid (MPA)		18 days
Primary	Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA		18 days
Primary	AUC extrapolated to infinity (AUC[INF]) of MPA		18 days
Secondary	Number of adverse events (AE)		Up to 48 days
Secondary	Number of serious adverse events (SAE)		Up to 48 days
Secondary	Number of AEs leading to discontinuation		Up to 48 days
Secondary	Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results		18 days

External Links

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