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

Immunology Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017730
• Other study ID #: IM136-106
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2013
• Last updated: July 3, 2015
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

End point Classification: Pharmacokinetics/Pharmacodynamics

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Immunology

Intervention

Drug:
• BMS-986020

• [11C]BMT-136088

Locations

Country	Name	City	State
United States	Yale Pet Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall safety and tolerability of novel tracer [11C]BMT-136088	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.	Approximately up to 90 days	Yes
Primary	Lung LPA1 percentage receptor occupancy of BMS-986020	Assessed by [11C]BMT-136088 tracer lung volume of distribution (VT) before and after single oral dose of BMS-986020.	Up to 2 days post BMS-986020 administration	Yes
Secondary	Exposure-response relationship between lung LPA1 percentage receptor occupancy and BMS-986020 plasma concentration.		Up to 48 hr postdose (Approximately up to Day 3)	No
Secondary	Maximum observed concentration (Cmax) of BMS-986020		13 timepoints up to Day 3	No
Secondary	Time of maximum observed concentration (Tmax) of BMS-986020		13 timepoints up to Day 3	No
Secondary	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	No
Secondary	Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986020		13 timepoints up to Day 3	No
Secondary	Half life (T-HALF) of BMS-986020		13 timepoints up to Day 3	No
Secondary	Safety of single oral dose of BMS-986020 where [11C]BMT-136088 is administered to healthy subjects	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	Approximately up to 90 days	Yes

External Links

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