To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding in Lung Using PET (Positron Emission Tomography) In Healthy Volunteers

Completed · Phase 1

Conditions studied: Immunology

In brief

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.

Key facts

Study ID

NCT02017730

Run by

Bristol-Myers Squibb

People needed

20

Starts

2014-01-01

Expected to finish

2015-01-01

Last updated by the study team

2015-07-07

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale Pet Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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