WithdrawnNCT04082741Updated Jan 27, 2020

A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants

A Phase 1 interventional study of BMS-986318 and Placebo in Healthy Participants, sponsored by Bristol-Myers Squibb. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-27.

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

Why this study was withdrawn

The study is no longer required based on nonclinical drug data

Phase: Phase 1
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.

Read the detailed description

A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants

Conditions studied

Healthy Participants

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator
Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days.
Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment.

Exclusion criteria

Exclusion Criteria:

Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration
Women of Child Bearing Potential (WOCBP) or women who are breastfeeding.
Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 0 participants (actual)

Study arms

Experimental
Monotherapy SAD BMS-986318 or Placebo
Single Ascending Dose (SAD)
Drug: BMS-986318 · Other: Placebo
Experimental
Monotherapy MAD BMS-986318 or Placebo
Multiple Ascending Dose (MAD)
Drug: BMS-986318 · Other: Placebo

Interventions

DrugBMS-986318
Specified dose on specified days
OtherPlacebo
Placebo Matching BMS-986318

What researchers measure

Primary outcomes

Incidence of non-serious adverse events (AEs)
Time frame: up to 30 days
Incidence of Serious Adverse Events (SAE)
Time frame: up to 30 days
Incidence of AEs leading to discontinuation of study treatment
Time frame: up to 30 days
Physical Examination of height
Time frame: up to 30 days
Physical Examination of weight
Time frame: up to 30 days
Physical Examination of BMI
Time frame: up to 30 days
Assessment of body temperature
Time frame: up to 30 days
Assessment of respiratory rate
Time frame: up to 30 days
Assessment of blood pressure
Time frame: up to 30 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time frame: up to 30 days
Number of clinical significant changes in lab assessment of blood serum
Time frame: up to 30 days
Number of Clinically significant changes in assessment of blood
Time frame: up to 30 days
Number of Clinically significant changes in lab assessment of urine
Time frame: up to 30 days

Study locations

1 site

PRA Health Sciences - Lenexa
Lenexa, Kansas 66219, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04082741
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Sep 9, 2019
Start date: Jul 18, 2019
Primary completion: Sep 12, 2019
Completion: Sep 12, 2019
Last update: Jan 27, 2020

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 ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor