NCT04305899|CompletedPhase 1FDA Drug

A Study to Compare the Taste and Levels in Blood Plasma of BMS-986165 When Taken as Different Formulations by Healthy Adult Participants

An Open-Label Cross-Over Study to Compare Bioavailability, Dose Proportionality, and Palatability of Single Doses of BMS-986165 Minitablet Pediatric Formulation in Fasted and Fed Conditions Relative to Single Doses of BMS-986165 Clinical Formulations In Healthy Adult Participants

Bristol-Myers Squibb ClinicalTrials.gov

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1 other identifier

IM011-113

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2020

StartedAug 2020

CompletionNov 2020

Brief Summary

The purpose of this study is to compare the taste, and the levels in blood plasma of different tablet formulations of BMS-986165 when taken by healthy adults.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Aug 2020

Shorter than P25 for phase_1

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3 months study duration

First Submitted

Initial submission to the registry

March 10, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

August 31, 2020

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2020

Completed

Last Updated

November 11, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

March 10, 2020

Last Update Submit

November 9, 2021

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

Maximum concentration (Cmax) in plasma for BMS-986165
Up to 26 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165
Up to 26 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) in plasma for BMS-986165
Up to 26 days

Secondary Outcomes (12)

Incidence of Adverse Events (AEs)
Up to 26 days
Incidence of Serious Adverse Events (SAEs)
Up to 98 days
Incidence of clinically significant changes in physical examination findings
Up to 68 days
Incidence of clinically significant changes in vital signs: Weight
Up to 68 days
Incidence of clinically significant changes in vital signs: Body temperature
Up to 68 days
+7 more secondary outcomes