Clinical trial NCT04082741: A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of non-serious adverse events (AEs)
timeFrame: up to 30 days
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: up to 30 days
measure: Incidence of AEs leading to discontinuation of study treatment
timeFrame: up to 30 days
measure: Physical Examination of height
timeFrame: up to 30 days
measure: Physical Examination of weight
timeFrame: up to 30 days
measure: Physical Examination of BMI
timeFrame: up to 30 days
measure: Assessment of body temperature
timeFrame: up to 30 days
measure: Assessment of respiratory rate
timeFrame: up to 30 days
measure: Assessment of blood pressure
timeFrame: up to 30 days
measure: Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
timeFrame: up to 30 days
measure: Number of clinical significant changes in lab assessment of blood serum
timeFrame: up to 30 days
measure: Number of Clinically significant changes in assessment of blood
timeFrame: up to 30 days
measure: Number of Clinically significant changes in lab assessment of urine
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences - Lenexa
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: