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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety, Tolerability, Kinetics and Repeatability of 18F-BMS-986327

NCT04069143

Healthy Participants Idiopathic Pulmonary Fibrosis (IPF)

COMPLETED PHASE1

ONO-2952 Single-dose PET Study in Healthy Adult Subjects

NCT01613703

Healthy Adult Subjects

COMPLETED PHASE1

An Open Label Positron Emission Tomography (PET) Study to Determine Central mGluR5 Receptor Occupancy of AZD2516

NCT00892944

Healthy

COMPLETED PHASE1

A Study of [11C]JNJ-42491293, a Possible PET Ligand for the mGlu2 Receptor, in Healthy Adult Volunteers

NCT01359852

Healthy

COMPLETED PHASE1

Test Re-Test Reliability of [11C]PF-06809247 as a Novel PET Tacer

NCT03100136

Neuroinflammation

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

End point Classification: Pharmacokinetics/Pharmacodynamics

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immunology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part 1: [11C]BMT-136088 (Safety Study)

Single PET SCAN with single bolus injection of \[11C\]BMT-136088

Group Type EXPERIMENTAL

[11C]BMT-136088

Intervention Type DRUG

Part 2: [11C]BMT-136088 (Test/Retest study)

Single PET SCAN with Intravenous (IV) bolus plus infusion of \[11C\]BMT-136088 followed by a re-test PET scan (approximately 6 hours apart) with IV bolus plus infusion of \[11C\]BMT-136088

Group Type EXPERIMENTAL

[11C]BMT-136088

Intervention Type DRUG

Part 3: BMS-986020+[11C]BMT-136088 (Receptor Occupancy study)

BMS-986020 Tablets or Oral Solution of 4 dose levels from from the 6 dose levels of (50 mg, 150 mg, 300 mg, 600 mg, 1200 mg and 1500 mg) and 3 PET SCANS (Pre-Dose, Post-Dose1, Post-Dose2) with bolus plus infusion of \[11C\]BMT-136088

Group Type EXPERIMENTAL

BMS-986020

Intervention Type DRUG

[11C]BMT-136088

Intervention Type DRUG

Part 4: [11C]BMT-136088 (Tissue Distribution study)

Single PET SCAN with \[11C\]BMT-136088 to evaluate additional tracer uptake sites in humans other than the lung, such as heart, kidney, liver, gallbladder, etc.

Group Type EXPERIMENTAL

[11C]BMT-136088

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986020

Intervention Type DRUG

[11C]BMT-136088

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes