Clinical trial NCT02017730: To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding in Lung Using PET (Positron Emission Tomography) In Healthy Volunteers
Official title: An Open-Label Study To Evaluate The Safety and Tolerability Of A Novel LPA1 Receptor Positron Emission Tomography (PET) Ligand [11C]BMT-136088 And To Assess Receptor Occupancy In Human Lung Following Oral Administration Of BMS-986020 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immunology
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-12-23
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the safety and tolerability of a novel positron emission tomography (PET) tracer \[11C\]BMT-136088 in healthy adult subjects for measurement of availability of Lysophosphatidic Acid (LPA1) receptors in the human lung and to use this tracer to assess LPA1 receptor occupancy using \[11C\]BMT-136088 in the human lung following oral administration of Bristol Myers Squibb (BMS)-986020.

Detailed description: End point Classification: Pharmacokinetics/Pharmacodynamics

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

Inclusion Criteria:

* Body weight at least 50kg (110lbs), Body Mass Index (BMI) within 19 to 32 kg/m2, inclusive
* Must be in good health as determined by medical history, physical examination, ECG, serum/urine biochemistry, hematology, and serology tests
* Negative hepatitis panel and negative human immunodeficiency virus (HIV)antibody screens

Exclusion Criteria:

* Any history or presence of clinically significant respiratory, Gastro Intestinal (GI), renal, hepatic, pancreatic, hematological, neurological (including history of seizure), cardiovascular, psychiatric (including known addictive disorders), musculoskeletal, genitourinary, immunological, or dermatological disorders, including all cancers
* Any acute or chronic condition that, in the opinion of the investigator in consultation with the BMS Medical Monitor, could jeopardize the subject's safety, tolerability, or pharmacokinetics of the BMS-986020
* Any major surgery within 4 weeks of study drug administration
* Existence of a cold, upper respiratory tract infection, or fever within 5 days prior to check-in
* Presence or history of any abnormality or illness that may affect absorption, distribution, metabolism or elimination of the study drug
* Donation of blood or plasma (exclude the screening visit) within 2 months prior to check in through end of synthesis (EOS), inclusive

Primary outcomes:
measure: Overall safety and tolerability of novel tracer [11C]BMT-136088
timeFrame: Approximately up to 90 days
measure: Lung LPA1 percentage receptor occupancy of BMS-986020
timeFrame: Up to 2 days post BMS-986020 administration
Secondary outcomes:
measure: Exposure-response relationship between lung LPA1 percentage receptor occupancy and BMS-986020 plasma concentration.
timeFrame: Up to 48 hr postdose (Approximately up to Day 3)
measure: Maximum observed concentration (Cmax) of BMS-986020
timeFrame: 13 timepoints up to Day 3
measure: Time of maximum observed concentration (Tmax) of BMS-986020
timeFrame: 13 timepoints up to Day 3
measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986020
timeFrame: 13 timepoints up to Day 3
measure: Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986020
timeFrame: 13 timepoints up to Day 3
measure: Half life (T-HALF) of BMS-986020
timeFrame: 13 timepoints up to Day 3
measure: Safety of single oral dose of BMS-986020 where [11C]BMT-136088 is administered to healthy subjects
timeFrame: Approximately up to 90 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Pet Center
state: Connecticut
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: