Immunology
Conditions
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
Interventions
DRUGBMS-986020
DRUG[11C]BMT-136088
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall safety and tolerability of novel tracer [11C]BMT-136088 | Approximately up to 90 days | The following safety endpoints will be considered, the incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation from the study, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiograms (ECGs), and physical examinations occurring from screening up to study discharge. |
| Lung LPA1 percentage receptor occupancy of BMS-986020 | Up to 2 days post BMS-986020 administration | Assessed by \[11C\]BMT-136088 tracer lung volume of distribution (VT) before and after single oral dose of BMS-986020. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of maximum observed concentration (Tmax) of BMS-986020 | 13 timepoints up to Day 3 | — |
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986020 | 13 timepoints up to Day 3 | — |
| Exposure-response relationship between lung LPA1 percentage receptor occupancy and BMS-986020 plasma concentration. | Up to 48 hr postdose (Approximately up to Day 3) | — |
| Half life (T-HALF) of BMS-986020 | 13 timepoints up to Day 3 | — |
| Safety of single oral dose of BMS-986020 where [11C]BMT-136088 is administered to healthy subjects | Approximately up to 90 days | Safety based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations |
| Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986020 | 13 timepoints up to Day 3 | — |
| Maximum observed concentration (Cmax) of BMS-986020 | 13 timepoints up to Day 3 | — |
Countries
United States
Outcome results
None listed