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

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

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03035734
Enrollment
0
Registered
2017-01-30
Start date
2017-01-25
Completion date
2017-02-07
Last updated
2018-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGBMS-986141 Form A Tablet

tablet

DRUGBMS-986141 Form B tablet (low dose)

tablet

DRUGBMS-986141 Form B tablet (high dose)

tablet

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet4 weeks

Secondary

MeasureTime frame
Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026