Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants

Healthy Clinical Trial

Official title:

A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy Participants

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03035734
• Other study ID #: CV006-023
• Secondary ID: 2016-001031-13
• Status: Withdrawn
• Phase: Phase 1
• First received: December 23, 2016
• Last updated: March 21, 2018
• Start date: January 25, 2017
• Est. completion date: February 7, 2017

Study information

• Verified date: March 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments

• Body mass index 18.0 kg/m2 to 32.0 kg/m2

• females must be of non-childbearing potential

Exclusion Criteria:

• known bleeding or coagulation disorders

• acute or chronic medical illness

• history of nausea or chronic diarrhea that lasts over 4 weeks

• history of periodontal disease or gingivitis which required treatment

• other exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BMS-986141 Form A Tablet
tablet
• BMS-986141 Form B tablet (low dose)
tablet
• BMS-986141 Form B tablet (high dose)
tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet		4 weeks
Secondary	Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct		4 weeks

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
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•   Investigator inquiry form