Back to resultsA Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Primary Purpose
Fibrosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986263
Placebo
Diphenhydramine
Famotidine
Sponsored by
About this trial
This is an interventional screening trial for Fibrosis
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Healthy participants as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
- Weight within the range of ≥60 and ≤90 kg
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
- WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days), plus 5 half-lives of BMS-986263 (7.5 days) plus 30 days (duration of ovulatory cycle) for a total of 90 days post-treatment completion
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days) plus 5 half-lives of BMS-986263 (7.5 days) plus the duration of sperm turnover (90 days) for a total of 118.5 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements
Exclusion Criteria:
- History or evidence of active infection and/or febrile illness within 7 days of Study Day 1 (e.g., bronchopulmonary, urinary, gastrointestinal, etc.)
- History of serious bacterial, fungal, or viral infections that let to hospitalization and IV antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of Study Day 1
- History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection, or skin infection (recurrent or chronic infection is defined as ≥2 episodes within a 6 month period)
- Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history)
- History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Presence of active tuberculosis (TB), latent TB, or inadequately treated latent or active TB
Other protocol defined inclusion/exclusion criteria could apply
Sites / Locations
- Wcct Global, Llc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BMS-986263
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events (AE)
measured by incidences
Serious Adverse Events (SAE)
measured by incidences
Infusion related reactions
measured by incidences
Abnormalities in clinical laboratory tests
measured by incidences
Abnormal vital sign measurements
measured by incidences
Abnormal electrocardiogram measurements
measured by incidences
Physical examination abnormalities
measured by incidences
Secondary Outcome Measures
Cmax
Maximum observed plasma concentration
Tmax
Time of maximum observed plasma concentration
AUC(0-T)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
AUC(TAU)
Area under the concentration-time curve in one dosing interval (multiple dose only)
T-HALF
Terminal phase half-life
CLT
Total body clearance after IV dose
AI_AUC
Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only)
T-HALFeff_AUC
Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only)
Ctrough
Trough observed plasma concentration
Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients
Investigation of population specific differences in PK
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03142165
Brief Title
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
November 29, 2017 (Actual)
Study Completion Date
November 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrosis
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-986263
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986263
Intervention Description
3 weekly doses of 90 mg infused intravenous administration
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Diphenhydramine
Intervention Description
50 mg intravenous administration
Intervention Type
Drug
Intervention Name(s)
Famotidine
Intervention Description
20 mg intravenous administration
Primary Outcome Measure Information:
Title
Adverse Events (AE)
Description
measured by incidences
Time Frame
28 days
Title
Serious Adverse Events (SAE)
Description
measured by incidences
Time Frame
30 days
Title
Infusion related reactions
Description
measured by incidences
Time Frame
28 days
Title
Abnormalities in clinical laboratory tests
Description
measured by incidences
Time Frame
28 days
Title
Abnormal vital sign measurements
Description
measured by incidences
Time Frame
28 days
Title
Abnormal electrocardiogram measurements
Description
measured by incidences
Time Frame
28 days
Title
Physical examination abnormalities
Description
measured by incidences
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum observed plasma concentration
Time Frame
28 days
Title
Tmax
Description
Time of maximum observed plasma concentration
Time Frame
28 days
Title
AUC(0-T)
Description
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration
Time Frame
28 days
Title
AUC(TAU)
Description
Area under the concentration-time curve in one dosing interval (multiple dose only)
Time Frame
28 days
Title
T-HALF
Description
Terminal phase half-life
Time Frame
28 days
Title
CLT
Description
Total body clearance after IV dose
Time Frame
28 days
Title
AI_AUC
Description
Accumulation Index, the ratio of AUC(TAU) at steady-state to that after the first dose (Day 15 only)
Time Frame
28 days
Title
T-HALFeff_AUC
Description
Effective elimination half-life that explains the degree of accumulation observed for AUC(TAU) (Day 15 only)
Time Frame
28 days
Title
Ctrough
Description
Trough observed plasma concentration
Time Frame
28 days
Title
Comparison of pharmacokinetic (PK) parameters in non-Japanese versus Japanese patients
Description
Investigation of population specific differences in PK
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Healthy participants as determined by no clinically significant deviation from normal in medical history, physical exam, ECGs, and clinical laboratory determinations
Weight within the range of ≥60 and ≤90 kg
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug
WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days), plus 5 half-lives of BMS-986263 (7.5 days) plus 30 days (duration of ovulatory cycle) for a total of 90 days post-treatment completion
Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986263 (21 days) plus 5 half-lives of BMS-986263 (7.5 days) plus the duration of sperm turnover (90 days) for a total of 118.5 days post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements
Exclusion Criteria:
History or evidence of active infection and/or febrile illness within 7 days of Study Day 1 (e.g., bronchopulmonary, urinary, gastrointestinal, etc.)
History of serious bacterial, fungal, or viral infections that let to hospitalization and IV antibiotic treatment within 90 days prior to screening, or any recent serious infection requiring antibiotic treatment within 30 days of Study Day 1
History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection, or skin infection (recurrent or chronic infection is defined as ≥2 episodes within a 6 month period)
Active herpes infection, including herpes simplex 1 and 2 and herpes zoster (demonstrated on physical examination and/or medical history)
History of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Presence of active tuberculosis (TB), latent TB, or inadequately treated latent or active TB
Other protocol defined inclusion/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Wcct Global, Llc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
12. IPD Sharing Statement
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986263 in Healthy Participants
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