Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020

Phase 1

Completed

• Conditions: Immunosuppression For Disease
• Interventions: Drug: [14C] BMS-986020

• Registration Number: NCT02068053
• Lead Sponsor: Bristol-Myers Squibb

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

Study Timeline

• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-20
• Study Start: 2014-03
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-30
• Last Update Posted: 2014-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A - BMS-986020	[14C] BMS-986020	600 mg (approximately 80 micro Curie) of \[14C\] BMS-986020 Single Dose for 1 Day (Day 1) orally

Primary Outcome Measures

Name	Time	Method
Area under the concentration time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986020 and TRA	22 Timepoints up to Day 11
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	22 Timepoints up to Day 11
Area under the concentration time curve from time zero to 168 hours postdose (AUC(0-168)) of BMS-986020 and TRA	19 Timepoints up to Day 8
Maximum observed plasma concentration (Cmax) of BMS-986020 and Total Radioactivity (TRA)	22 Timepoints up to Day 11
Time of maximum observed plasma concentration (Tmax) of BMS-986020 and TRA	22 Timepoints up to Day 11
Terminal plasma half-life (T-Half) of BMS-986020 and TRA	22 Timepoints up to Day 11
Apparent total body clearance (CL/F) of BMS-986020	19 Timepoints up to Day 8
Percent of plasma BMS-986020 AUC(0-T) (%AUC(0-T)) relative to plasma TRA AUC(0-T)	22 Timepoints up to Day 11
Percent of plasma BMS-986020 AUC(INF) (%AUC(INF)) relative to plasma TRA AUC(INF)	22 Timepoints up to Day 11
Percent of total administered radioactivity excreted in urine (% UR)	13 Timepoints up to Day 11
Percent of total administered radioactivity excreted in feces (% FE)	11 Timepoints up to Day 11
Percent of total administered radioactivity recovered in urine and feces (%TOTAL)	13 Timepoints up to Day 11

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Event (AE)s collected during the study will be reviewed for potential significance and clinical importance	Upto Day 11
Clinical laboratory test results: Safety laboratory testing will be drawn at specified times	Up to Day 11
Vital Signs: Blood pressure, heart rate, respiratory rate, and body temperature measurements will be assessed at specified time points	Up to Day 11
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	Up to Day 11
Physical examinations: Physical examinations will be assessed at the time points	Up to Day 11