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

Phase 1

Withdrawn

• Conditions: Healthy Participants
• Interventions: Drug: BMS-986318; Other: Placebo

• Registration Number: NCT04082741
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-18
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Primary Completion: 2019-09-12
• Study Completion: 2019-09-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy SAD BMS-986318 or Placebo	BMS-986318	Single Ascending Dose (SAD)
Monotherapy SAD BMS-986318 or Placebo	Placebo	Single Ascending Dose (SAD)
Monotherapy MAD BMS-986318 or Placebo	BMS-986318	Multiple Ascending Dose (MAD)
Monotherapy MAD BMS-986318 or Placebo	Placebo	Multiple Ascending Dose (MAD)

Primary Outcome Measures

Name	Time	Method
Incidence of non-serious adverse events (AEs)	up to 30 days
Incidence of Serious Adverse Events (SAE)	up to 30 days
Assessment of respiratory rate	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
Incidence of AEs leading to discontinuation of study treatment	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
Physical Examination of height	up to 30 days
Assessment of blood pressure	up to 30 days
Number of Clinically significant changes in lab assessment of urine	up to 30 days

Trial Locations

Locations (1)

PRA Health Sciences - Lenexa; 🇺🇸 Lenexa, Kansas, United States