Clinical trial NCT04926051: A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption
Official title: A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Healthy Participants
BMS-986172
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.


Eligibility criteria: Inclusion Criteria:

* Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.
* Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for \<10 years.
* BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.

Exclusion Criteria:

* Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.
* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.
* Any significant acute or chronic medical illness.
* History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent
* Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Incidence of non-serious Adverse Events (AEs)
timeFrame: Up to 35 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 35 days
measure: Incidence of AEs leading to discontinuation of study treatment
timeFrame: Up to 35 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in physical examination
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in clinical laboratory values: Hematology tests
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in clinical laboratory values: Serology tests
timeFrame: Up to 28 days
measure: Incidence of clinically significant changes in ECG parameters: QTcF
timeFrame: Up to 28 days
Secondary outcomes:
measure: Plasma concentrations of BMS-986172
timeFrame: Up to 28 days
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 28 days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Plc (Legacy PRA)
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: