Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects

June 16, 2020 updated by: Bristol-Myers Squibb

A Randomized, Double-Blind, Placebo-Controlled, Single- And Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-986165 in Healthy Chinese Subjects

Main objective of this study is to assess BMS-986165 plasma PK following single and multiple oral doses of BMS-986165 in healthy Chinese subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed Informed Consent.
  • Healthy participants, as determined by physical examination, ECGs, and clinical laboratory and procedure determinations.
  • Body mass index (BMI) of 18 to 24 kg/m2, inclusive, and total body weight >= 50 kg.

Exclusion Criteria:

  • History of allergy to drug class or related compounds.
  • History or evidence of active infection within 7 days of study day 1.
  • Drug or alcohol abuse within 6 months of study treatment administration.

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: BMS-986165 Dose 1
Participants will receive Dose 1 on Day 1, and from Day 5 - 19.
Drug: BMS-986165
Dose 1 or Dose 2 on Day 1, and from Days 5-19'
Experimental: Group 2: BMS-986165 Dose 2
Participants will receive Dose 2 on Day 1, and from Day 5 - 19.
Drug: BMS-986165
Dose 1 or Dose 2 on Day 1, and from Days 5-19'
Placebo Comparator: Group 1: Placebo Dose 1
Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.
Other: Placebo
Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19
Placebo Comparator: Group 2: Placebo Dose 2
Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.
Other: Placebo
Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of BMS-986165
Time Frame: Day 1 to Day 4
Day 1 to Day 4
Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Apparent Oral Total Body Clearance (CLT/F) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Metabolic Ratio for AUC(INF) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[INF])
Time Frame: Day 1 to Day 4
Day 1 to Day 4
Metabolic Ratio for Cmax of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(Cmax)
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Apparent Volume of Distribution (Vz/F) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165
Time Frame: Day 5 to Day 19
Day 5 to Day 19
Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165
Time Frame: Day 5 and Day 19
Day 5 and Day 19
Effective Elimination Half-Life (T-HALFeff) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Trough Observed Plasma Concentration (Ctrough) of BMS-986165
Time Frame: Day 2 to 20
Day 2 to 20
Average Plasma Concentration at Steady State (Css-avg) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Accumulation Index (AI) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Metabolic Ratio for AUC(TAU) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[TAU])
Time Frame: Day 5 to Day 19
Day 5 to Day 19
Degree of Fluctuation (DF) of BMS-986165
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with Adverse Events (AEs)
Time Frame: Up to Day 31
Up to Day 31
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
Time Frame: Up to Day 24
Up to Day 24
Number of Participants With Clinically Significant Change in Vital Signs
Time Frame: Up to Day 24
Up to Day 24
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
Time Frame: Up to Day 24
Up to Day 24
Number of Participants With Clinically Significant Change in Physical Examination
Time Frame: Up to Day 24
Up to Day 24
Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Time to Maximum Observed Plasma Concentration (Tmax) of B Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Average Plasma Concentration at Steady State (Css-avg) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170
Time Frame: Days 1 to 4, Day 5, and Day 19
Days 1 to 4, Day 5, and Day 19
Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165
Time Frame: Day 1 to Day 5
Day 1 to Day 5
Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165
Time Frame: Day 1 to Day 5
Day 1 to Day 5
Renal Clearance (CLR) Following Single Oral Doses of BMS-986165
Time Frame: Day 1 to Day 5
Day 1 to Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM011-053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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