NCT03541564

Brief Summary

This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2018

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 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

May 17, 2018

Last Update Submit

January 24, 2020

Conditions

Systemic Lupus ErythematosusHealthy Participants

Outcome Measures

Primary Outcomes (1)

  • Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)

    From baseline to 5 days

Secondary Outcomes (12)

  • Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG

    From baseline to 5 days

  • Heart rate (HR) as determined by 12-lead ECG

    5 days

  • QRS as determined by 12-lead ECG

    5 days

  • PR as determined by 12-lead ECG

    5 days

  • Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG

    From baseline to 5 days

  • +7 more secondary outcomes

Study Arms (4)

BMS-986165 Dose 1 oral administration

EXPERIMENTAL

BMS-986165 therapeutic single dose

Drug: BMS-986165

BMS-986165 Dose 2 oral administration

EXPERIMENTAL

BMS-986165 supratherapeutic single dose

Drug: BMS-986165

Moxifloxacin Dose 3 oral administration

ACTIVE COMPARATOR

Moxifloxacin positive control single dose

Drug: Moxifloxacin

Placebo Dose 4 oral administration

PLACEBO COMPARATOR

Placebo single dose

Other: Placebo

Interventions

BMS-986165DRUG

Specified dose on specified days

BMS-986165 Dose 1 oral administrationBMS-986165 Dose 2 oral administration
MoxifloxacinDRUG

Specified dose on specified days

Moxifloxacin Dose 3 oral administration
PlaceboOTHER

Specified dose on specified days

Placebo Dose 4 oral administration

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator
  • Body mass index of 18.0 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening
  • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.732 m2

You may not qualify if:

  • Any medical condition that presents a potential risk and/or may compromise the objectives of the study, including a history or presence of active liver disease
  • A personal history of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
  • History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

deucravacitinibMoxifloxacin

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-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
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

May 30, 2018

Study Start

May 30, 2018

Primary Completion

September 4, 2018

Study Completion

September 4, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

US(1)