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

NCT02068053 | Completed Phase 1

• 1 other identifier: IM136-006
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immunosuppression For Disease

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• 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

• 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 Outcomes (5)

• 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

Study Arms (1)

Arm A - BMS-986020

EXPERIMENTAL

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

Drug: [14C] BMS-986020

Interventions

[14C] BMS-986020 DRUG

Also known as: Lysophosphatidic Acid receptor 1 (LPA1) Antagonist

Arm A - BMS-986020

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 20, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 2, 2014

Record last verified: 2014-05