Clinical trial NCT03445208: A Study of Experimental Medication BMS-986036 Given to Healthy Participants
Official title: An Open-Label, Single-Dose, Fixed-Sequence Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 Administered to the Abdomen and Upper Arm in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Cirrhosis
Liver Fibrosis
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study of experimental medication BMS-986036 given to healthy participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* BMI of 18 to ≤ 40 kg/m2

Exclusion Criteria:

* Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
* Any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
* Known or suspected autoimmune disorder, excluding vitiligo
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 6 weeks of study drug administration
* History of diabetes mellitus

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: 29 days
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: 29 days
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]
timeFrame: 29 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]
timeFrame: 29 days
Secondary outcomes:
measure: Number of injection site reactions
timeFrame: Up to 78 days
measure: Number of adverse events (AE)
timeFrame: Up to 78 days
measure: Number of serious adverse events (SAE)
timeFrame: Up to 78 days
measure: Number of AEs leading to discontinuation
timeFrame: Up to 78 days
measure: Number of deaths
timeFrame: Up to 78 days
measure: Serum biomarker antibody concentration
timeFrame: Up to 78 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: