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

NCT04082741 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IM031-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (13)

• Incidence of non-serious adverse events (AEs)

  up to 30 days

• Incidence of Serious Adverse Events (SAE)

  up to 30 days

• Incidence of AEs leading to discontinuation of study treatment

  up to 30 days

• Physical Examination of height

  up to 30 days

• Physical Examination of weight

  up to 30 days

• Physical Examination of BMI

  up to 30 days

• Assessment of body temperature

  up to 30 days

• Assessment of respiratory rate

  up to 30 days

• Assessment of blood pressure

  up to 30 days

• Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities

  up to 30 days

• Number of clinical significant changes in lab assessment of blood serum

  up to 30 days

• Number of Clinically significant changes in assessment of blood

  up to 30 days

• Number of Clinically significant changes in lab assessment of urine

  up to 30 days

Study Arms (2)

Monotherapy SAD BMS-986318 or Placebo

EXPERIMENTAL

Single Ascending Dose (SAD)

Drug: BMS-986318; Other: Placebo

Monotherapy MAD BMS-986318 or Placebo

EXPERIMENTAL

Multiple Ascending Dose (MAD)

Drug: BMS-986318; Other: Placebo

Interventions

BMS-986318 DRUG

Specified dose on specified days

Monotherapy MAD BMS-986318 or Placebo; Monotherapy SAD BMS-986318 or Placebo

Placebo OTHER

Placebo Matching BMS-986318

Monotherapy MAD BMS-986318 or Placebo; Monotherapy SAD BMS-986318 or Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PRA Health Sciences - Lenexa

Lenexa, Kansas, 66219, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: September 9, 2019
• Study Start: July 18, 2019
• Primary Completion: September 12, 2019
• Study Completion: September 12, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (1)