NCT02084953

Brief Summary

The purpose of this study is to determine whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2014

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

March 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

1 month

First QC Date

March 10, 2014

Last Update Submit

July 25, 2014

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Difference from placebo of BMS-791325 in time-matched change from baseline (Day -1 on the study) to Day 3 of each period (ΔΔQTcF) at postdose extraction times for the QTcF

    Approximately 28 days

Secondary Outcomes (11)

  • ΔΔHR, ΔΔPR, ΔΔQRS, ΔΔQT

    Approximately 28 days

  • Number and percent of subjects having a within-period maximum HR, PR, QRS, QT, QTcF, ΔQT and ΔQTcF within prespecified categories

    Approximately 28 days

  • Relationship between plasma concentrations of BMS-791325, BMS-794712, and BMS-948158, and the corresponding ΔΔQTcF

    Approximately 28 days

  • Maximum observed concentration (Cmax) of BMS-791325, BMS-794712, and BMS-948158

    43 timepoints up to day 26

  • Time of maximum observed concentration (Tmax) of BMS-791325, BMS-794712, and BMS-948158

    43 timepoints up to day 26

  • +6 more secondary outcomes

Study Arms (3)

ARM A: BMS-791325

EXPERIMENTAL

BMS-791325 600 mg tablet orally on 1st and 2nd day, then 900 mg on the 3rd day once a day for 3 days

Drug: BMS-791325

ARM B: Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin 400mg tablet orally once on third day

Drug: Moxifloxacin

ARM C: Placebo matching BMS-791325

PLACEBO COMPARATOR

Placebo matching BMS-791325 0 mg tablet orally once daily for 3 days

Drug: Placebo matching BMS-791325

Interventions

BMS-791325DRUG
ARM A: BMS-791325
MoxifloxacinDRUG
Also known as: Avelox®
ARM B: Moxifloxacin
Placebo matching BMS-791325DRUG
ARM C: Placebo matching BMS-791325

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women, ages 18 to 49 yr old
  • BMI 18 to 32
  • Women must not be pregnant or breastfeeding

You may not qualify if:

  • Any significant acute or chronic medical illness
  • A personal history of clinically relevant cardiac disease, 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
  • History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
  • Inability to swallow multiple tablets consecutively
  • Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec, Heart Rate (HR) \< 45 bpm
  • Second or third degree heart block prior to study drug
  • Positive urine screen for drugs of abuse
  • Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
  • Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) \> upper limit of normal (ULN), Aspartate aminotransferase (AST) \> ULN, Total bilirubin \> ULN, Direct bilirubin \> ULN, Creatinine \> ULN, Serum potassium \< lower limit of normal (LLN), Serum magnesium \< LLN
  • History of allergy to Moxifloxacin, BMS-791325, nonstructural protein 5B (NS5B) non-nucleoside inhibitors or related compounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ppd Development, Llc

Austin, Texas, 78744, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamideMoxifloxacin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive 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
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 12, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

US(1)