NCT03142165

Brief Summary

The purpose of this study is to assess the safety and tolerability of BMS-986263 in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 11, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

May 3, 2017

Last Update Submit

January 10, 2018

Conditions

Fibrosis

Outcome Measures

Primary Outcomes (7)

  • Adverse Events (AE)

    measured by incidences

    28 days

  • Serious Adverse Events (SAE)

    measured by incidences

    30 days

  • Infusion related reactions

    measured by incidences

    28 days

  • Abnormalities in clinical laboratory tests

    measured by incidences

    28 days

  • Abnormal vital sign measurements

    measured by incidences

    28 days

  • Abnormal electrocardiogram measurements

    measured by incidences

    28 days

  • Physical examination abnormalities

    measured by incidences

    28 days

Secondary Outcomes (10)

  • Cmax

    28 days

  • Tmax

    28 days

  • AUC(0-T)

    28 days

  • AUC(TAU)

    28 days

  • T-HALF

    28 days

  • +5 more secondary outcomes

Study Arms (2)

BMS-986263

EXPERIMENTAL
Drug: BMS-986263Drug: DiphenhydramineDrug: Famotidine

Placebo

PLACEBO COMPARATOR
Other: PlaceboDrug: DiphenhydramineDrug: Famotidine

Interventions

BMS-986263DRUG

3 weekly doses of 90 mg infused intravenous administration

BMS-986263
PlaceboOTHER

Placebo

Placebo
DiphenhydramineDRUG

50 mg intravenous administration

BMS-986263Placebo
FamotidineDRUG

20 mg intravenous administration

BMS-986263Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wcct Global, Llc

Cypress, California, 90630, United States

Location

Related Links

MeSH Terms

Conditions

Fibrosis

Interventions

DiphenhydramineFamotidine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 5, 2017

Study Start

May 11, 2017

Primary Completion

November 29, 2017

Study Completion

November 29, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Locations

US(1)