To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding in Lung Using PET (Positron Emission Tomography) In Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | January 2014 |
| End Date: | January 2015 |
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
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.
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.
End point Classification: Pharmacokinetics/Pharmacodynamics
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
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