A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

Lupus Clinical Trial

Official title:

A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04065932
• Other study ID #: IM011-020
• Status: Completed
• Phase: Phase 1
• Start date: August 22, 2019
• Est. completion date: December 10, 2019

Study information

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

Clinical Trial Summary

A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 10, 2019
• Est. primary completion date: December 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Inclusion Criteria:

• Patients must be willing and able to complete all study-specific procedures and visits

• Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations

• Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening

• Normal renal function at screening

Exclusion Criteria:

• History or presence of chronic bacterial, viral infection, or autoimmune disorder

• Active TB requiring treatment or documented latent TB within the previous 3 years

• Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption

• WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.

Related Conditions & MeSH terms

• Lupus

Intervention

Drug:
• BMS-986165-01
Participants will receive BMS- 986165 -01 in prototype formulation
• BMS-986165 Tablet
Participants will receive BMS-986165 in tablet form.
• Famotidine
Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax) for BMS-986165		Day 1 of treatment
Primary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165		Day 1 of treatment
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165		Day 1 of treatment
Secondary	Time to maximum observed plasma concentration-(Tmax) for BMS -986165		Day 1 of treatment
Secondary	Apparent plasma elimination half-life- (T-HALF) for BMS-986165		Day 1 of treatment
Secondary	Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165		Day 1 of treatment
Secondary	Apparent clearance -(CL/F) for BMS-986165		Day 1 of treatment
Secondary	Concentration observed at 24 hours-(C24) for BMS-986165		Day 1 of treatment
Secondary	Concentration observed at 12 hours-(C12) for BMS-986165		Day 1 of treatment
Secondary	Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy.		Approximately 16 weeks
Secondary	Incidence of serious adverse events (SAE) leading to discontinuation of study therapy.		Approximately 16 weeks.
Secondary	Incidence of adverse events (AEs) leading to discontinuation of study therapy.		Approximately 16 weeks.

External Links

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