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Completed

NCT Number: NCT02017730

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

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.

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Key information

Conditions

Immunology

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Yale Pet Center

New Haven, Connecticut, 06520, United States

About this study

End point Classification: Pharmacokinetics/Pharmacodynamics

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986020

Drug

[11C]BMT-136088

Drug

Primary outcomes

  1. Overall safety and tolerability of novel tracer [11C]BMT-136088

    Time frame: 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.

  2. Lung LPA1 percentage receptor occupancy of BMS-986020

    Time frame: 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 outcomes

  1. Exposure-response relationship between lung LPA1 percentage receptor occupancy and BMS-986020 plasma concentration.

    Time frame: Up to 48 hr postdose (Approximately up to Day 3)

  2. Maximum observed concentration (Cmax) of BMS-986020

    Time frame: 13 timepoints up to Day 3

  3. Time of maximum observed concentration (Tmax) of BMS-986020

    Time frame: 13 timepoints up to Day 3

  4. Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986020

    Time frame: 13 timepoints up to Day 3

  5. Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986020

    Time frame: 13 timepoints up to Day 3

  6. Half life (T-HALF) of BMS-986020

    Time frame: 13 timepoints up to Day 3

  7. Safety of single oral dose of BMS-986020 where [11C]BMT-136088 is administered to healthy subjects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 23, 2013
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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