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Completed

NCT Number: NCT02084953

Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy Subjects

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).

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ppd Development, Llc

Austin, Texas, 78744, United States

About this study

Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

BMS-791325

Drug

moxifloxacin

Drug

Other names: Avelox®

Placebo matching BMS-791325

Drug

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

    Time frame: Approximately 28 days

Secondary outcomes

  1. ΔΔHR, ΔΔPR, ΔΔQRS, ΔΔQT

    Time frame: Approximately 28 days

    Difference from placebo in time-matched change from baseline (Day -1) to Day 3 at postdose extraction times in the ECG-derived RR or HR and other ECG intervals (PR, QRS, QT). QT is the unadjusted QT interval

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

    Time frame: Approximately 28 days

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

    Time frame: Approximately 28 days

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

    Time frame: 43 timepoints up to day 26

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

    Time frame: 43 timepoints up to day 26

  6. Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-791325, BMS-794712, and BMS-948158

    Time frame: 43 timepoints up to day 26

  7. Apparent total oral clearance (CLT/F) of BMS-791325, BMS-794712, and BMS-948158

    Time frame: 43 timepoints up to day 26

  8. Terminal phase plasma half life (T-HALF) of BMS-791325, BMS-794712, and BMS-948158

    Time frame: 43 timepoints up to day 26

  9. AUC(TAU) metabolic ratios of BMS-791325, BMS-794712, and BMS-948158

    Time frame: 43 timepoints up to day 26

  10. Incidence of AEs, SAEs, AEs leading to discontinuation and death, marked laboratory abnormalities, findings on 12-lead safety ECG measurements and physical examination, and abnormalities in vital sign measurements exceeding pre-defined thresholds

    Time frame: Up to day 28

    Adverse event (AEs)

    Serious adverse event (SAEs)

  11. Difference from placebo of Moxifloxacin in change from baseline (Day -1) to Day 3 at postdose extraction times for the QTcF (ΔΔQTcF)

    Time frame: Approximately 28 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-Blinded, Positive-Controlled, Placebo-Controlled, 3-Way Crossover Study to Determine the Electrocardiographic Effects of BMS-791325 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2014
Registry last updated
Jul 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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