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CompletedNCT03429933Updated Oct 1, 2019

A Study of Experimental Medication BMS-986278 Given to Healthy Participants

A Phase 1 interventional study of BMS-986278 and Placebo in Healthy Participants, sponsored by Bristol-Myers Squibb. Completed at 2 sites in 2 countries. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-01.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to investigate experimental medication BMS-986278 given to healthy participants.

02

Conditions studied

  • Healthy Participants
03

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

Inclusion Criteria:

  • Participants must be in good general health in the opinion of the investigator
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
  • Body weight between 55 and 105 kg, inclusive, at screening
  • Female participants must have documented proof that they are not of childbearing potential
  • Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)

Exclusion criteria

Exclusion Criteria:

  • Women who are of childbearing potential or breastfeeding
  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
  • History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
  • Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
  • Any major surgery within 6 weeks of study drug administration

Other protocol defined inclusion/exclusion criteria could apply

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    Single Ascending Dose

    BMS-986278 or placebo

    Drug: BMS-986278 · Other: Placebo

  • Experimental
    Multiple Ascending Dose

    BMS-986278 or placebo

    Drug: BMS-986278 · Other: Placebo

Interventions

  • DrugBMS-986278

    Specified dose on specified days

  • OtherPlacebo

    Specified dose on specified days

05

What researchers measure

Primary outcomes

  1. Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation

    Time frame: Up to 30 days

  2. Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations

    Time frame: Up to 30 days

06

Study locations

2 sites
  • Local Institution
    Groningen, 9728 NZ, Netherlands
  • Local Institution
    London, SE1 1YR, United Kingdom
07

References and documents

08

Registry details

Key details

Study ID
NCT03429933
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Feb 12, 2018
Start date
Feb 7, 2018
Primary completion
Mar 2, 2019
Completion
Mar 2, 2019
Last update
Oct 1, 2019

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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