A Study to Evaluate the Bioavailability of BMS-986205

Healthy Participants Clinical Trial

Official title:

A Study to Evaluate the Absolute Bioavailability of BMS-986205 Tablet Formulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374228
• Other study ID #: CA017-060
• Secondary ID: 2017-003100-51
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2018
• Est. completion date: February 16, 2018

Study information

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

Clinical Trial Summary

Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of [13C]BMS-986205 solution for intravenous administration in healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 16, 2018
• Est. primary completion date: February 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive

• Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula

• Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

• Women who are of childbearing potential or breastfeeding

• Any significant acute or chronic medical illness

• Active tuberculosis (TB) requiring treatment or documented latent TB at screening

Other protocol defined inclusion / exclusion criteria could apply

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986205
Specified Dose on Specified Days

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham	Ruddington Fields

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	Absolute oral bioavailability (F)	Measured by plasma concentration	Up to 15 days
Secondary	Occurrence of adverse events (AEs)	Safety and tolerability as measured by incidence of AEs	Up to 15 days
Secondary	Occurrence of serious adverse events (SAEs)	Safety and tolerability as measured by incidence of SAEs	Up to 15 days
Secondary	Occurrence of adverse events (AEs) leading to discontinuation	Safety and tolerability as measured by incidence of AEs leading to discontinuation	Up to 15 days
Secondary	Number of participants with vital sign measurement abnormalities		Up to 15 days
Secondary	Number of participants with electrocardiogram abnormalities		Up to 15 days
Secondary	Number of participants with physical examination abnormalities		Up to 15 days
Secondary	Number of participants with clinical laboratory test abnormalities		Up to 15 days

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form