Clinical trial NCT03674476: An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
Official title: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Varying Degrees of Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: NAFLD
Nonalcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.


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

Inclusion Criteria:

* BMI ≥ 25 and ≤ 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 (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration
* Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration
* Inability to tolerate subcutaneous injections

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Terminal elimination half-life (T-half) of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Total renal clearance (CLR) of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036
timeFrame: Up to 30 days
measure: Total amount excreted into urine (Ae) of C-terminal intact BMS-986036
timeFrame: Up to 30 days
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax) of total BMS-986036
timeFrame: Up to 30 days
measure: Time of maximum observed serum concentration (Tmax) of total BMS-986036
timeFrame: Up to 30 days
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036
timeFrame: Up to 30 days
measure: Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036
timeFrame: Up to 30 days
measure: Terminal elimination half-life (T-half) of total BMS-986036
timeFrame: Up to 30 days
measure: Apparent total body clearance (CLT/F) of total BMS-986036
timeFrame: Up to 30 days
measure: Apparent volume of distribution (Vz/F) of total BMS-986036
timeFrame: Up to 30 days
measure: Total renal clearance (CLR) of total BMS-986036
timeFrame: Up to 30 days
measure: Amount per fraction excreted into urine (Fe) of total BMS-986036
timeFrame: Up to 30 days
measure: Total amount excreted into urine (Ae) of total BMS-986036
timeFrame: Up to 30 days
measure: Incidence of injection site reactions (prospective)
timeFrame: Up to 30 days
measure: Incidence of adverse events (AE)
timeFrame: Up to 30 days
measure: Incidence of serious adverse events (SAE)
timeFrame: Up to 30 days
measure: Incidence of clinically significant changes to events of special interest
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Praha 7
country: Czechia
facility: Pharmaceutical Research Associates CZ, s.r.o
city: Budapest
country: Hungary
facility: PRA Magyarorszag Kft
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Miskolc
country: Hungary
facility: Clinical Research Unit Hungary
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: