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A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants

NCT03891108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-10-01

No results posted yet for this study

Summary

Main Objective of this study is to compare the single intravenous (IV) infusion pharmacokinetics (PK) of BMS-986231 and its metabolites (BMT-284730, BMT-279554, and CAR-000463) following of up to 2 test formulations of BMS-986231 relative to the reference formulation.

Conditions

Interventions

DRUG

BMS-986231 Formulation A

Participants will be administered BMS-986231 Formulation A as IV infusion for 48 hours.

DRUG

BMS-986231 Formulation B

Participants will be administered BMS-986231 Formulation B as IV infusion for 48 hours.

DRUG

BMS-986231 Formulation C

Participants will be administered BMS-986231 Formulation C as IV infusion for 48 hours.

DRUG

BMS-986231 Formulation D

Participants will be administered BMS-986231 Formulation D as IV infusion for 48 hours.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2019-07-29
Completion
2019-07-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891108 on ClinicalTrials.gov