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

NCT ID: NCT02068053

Last Updated: 2014-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-04-30

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

Conditions

Immunosuppression For Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Arm A - BMS-986020

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

Group Type: EXPERIMENTAL

[14C] BMS-986020

Intervention Type: DRUG

Interventions

[14C] BMS-986020

Intervention Type: DRUG

Other Intervention Names

Lysophosphatidic Acid receptor 1 (LPA1) Antagonist

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Other Identifiers

IM136-006

Identifier Type: -

Identifier Source: org_study_id