Clinical trial NCT02068053: Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020
Official title: Pharmacokinetics and Metabolism of [14C] BMS-986020 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immunosuppression For Disease
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-02-20
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, as well as safety and tolerability of a single oral solution dose of \[14C\] Bristol-Myers Squibb (BMS)-986020 in healthy male subjects.

Detailed description: Primary purpose: Other - This study will investigate the pharmacokinetic, biotransformation, routes of elimination, and mass balance of BMS-986020 in humans. The knowledge of the routes of elimination of the drug and its metabolites is useful for evaluating the likelihood of effects of renal or hepatic impairment on the disposition of BMS-986020

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body weight of at least 50 kg (110 lbs), Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. Body mass index = weight (kg)/\[height(m)\]2
* Men, ages 18 to 50 years, inclusive
* Men who are sexually active with women of childbearing potential (WOCBP) (except those with vasectomy with documented azoospermia 90 days after procedure) must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the investigational drug (4 days) plus 90 days (duration of sperm turnover) for a total of 94 days post-treatment completion

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Current or recent history of constipation or irregular bowel movements (less than once per 2 days)
* Any major surgery within 4 weeks of study drug administration
* Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
* History of Gilbert's Syndrome
* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
* Blood transfusion within 4 weeks of study drug administration
* Inability to tolerate oral medication
* Inability to be venipunctured and/or tolerate venous access
* Recent (within 6 months of study drug administration) history of smoking
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
* History of allergy to LPA1 antagonists or related compounds

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986020 and Total Radioactivity (TRA)
timeFrame: 22 Timepoints up to Day 11
measure: Time of maximum observed plasma concentration (Tmax) of BMS-986020 and TRA
timeFrame: 22 Timepoints up to Day 11
measure: Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of BMS-986020 and TRA
timeFrame: 22 Timepoints up to Day 11
measure: Area under the concentration time curve from time zero to 168 hours postdose (AUC(0-168)) of BMS-986020 and TRA
timeFrame: 19 Timepoints up to Day 8
measure: Area under the concentration time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986020 and TRA
timeFrame: 22 Timepoints up to Day 11
measure: Terminal plasma half-life (T-Half) of BMS-986020 and TRA
timeFrame: 22 Timepoints up to Day 11
measure: Apparent total body clearance (CL/F) of BMS-986020
timeFrame: 19 Timepoints up to Day 8
measure: Percent of plasma BMS-986020 AUC(0-T) (%AUC(0-T)) relative to plasma TRA AUC(0-T)
timeFrame: 22 Timepoints up to Day 11
measure: Percent of plasma BMS-986020 AUC(INF) (%AUC(INF)) relative to plasma TRA AUC(INF)
timeFrame: 22 Timepoints up to Day 11
measure: Percent of total administered radioactivity excreted in urine (% UR)
timeFrame: 13 Timepoints up to Day 11
measure: Percent of total administered radioactivity excreted in feces (% FE)
timeFrame: 11 Timepoints up to Day 11
measure: Percent of total administered radioactivity recovered in urine and feces (%TOTAL)
timeFrame: 13 Timepoints up to Day 11
Secondary outcomes:
measure: Incidence of Adverse Event (AE)s collected during the study will be reviewed for potential significance and clinical importance
timeFrame: Upto Day 11
measure: Clinical laboratory test results: Safety laboratory testing will be drawn at specified times
timeFrame: Up to Day 11
measure: Vital Signs: Blood pressure, heart rate, respiratory rate, and body temperature measurements will be assessed at specified time points
timeFrame: Up to Day 11
measure: Electrocardiogram (ECG): Regular ECG endpoints (heart rate, PR interval, QRS interval, and QT intervals corrected for heart rate) and investigator identified abnormalities will be assessed at the time points
timeFrame: Up to Day 11
measure: Physical examinations: Physical examinations will be assessed at the time points
timeFrame: Up to Day 11
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: