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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04082741
• Other study ID #: IM031-002
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 18, 2019
• Est. completion date: September 12, 2019

Study information

• Verified date: January 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986318
Specified dose on specified days

Other:
• Placebo
Placebo Matching BMS-986318

Locations

Country	Name	City	State
United States	PRA Health Sciences - Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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