Assessment of the Effect of BI 201335 on the QT Interval in Healthy Female and Male Subjects

NCT02182310 | Completed Phase 1

• 1 other identifier: 1220.16
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

To demonstrate that BI 201335 does not prolong the QT interval more than placebo. To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the cross-over part of the trial.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• QTcI interval (QT interval individually corrected for heart rate)

  pre-dose and 3 to 8 hours

Secondary Outcomes (3)

• The mean value of QTcI changes from baseline between 2 h and 24 h after dosing

  Pre dose and 2 to 24 hours post dosing

• The change from mean baseline of the QTcI at any point in time between 2 h and 24 h after dosing

  Pre dose and 2 to 24 hours post dosing

• The time-matched changes versus placebo in QTcI at any point in time between 2 h and 24 h after dosing

  Pre dose and 2 to 24 hours post dosing

Study Arms (5)

BI 201335 placebo

PLACEBO COMPARATOR

crossover part

Drug: BI 201335 placebo

BI 201335 low dose

EXPERIMENTAL

crossover part

Drug: BI 201335 low dose

BI 201335 high dose

EXPERIMENTAL

crossover part

Drug: BI 201335 high dose

Moxifloxacin

ACTIVE COMPARATOR

crossover part

Drug: Moxifloxacin

BI 201335 or Placebo

EXPERIMENTAL

tolerability part in female subjects

Drug: BI 201335 placebo; Drug: BI 201335 high dose

Interventions

BI 201335 low dose DRUG

BI 201335 low dose

BI 201335 placebo DRUG

BI 201335 or Placebo; BI 201335 placebo

Moxifloxacin DRUG

Moxifloxacin

BI 201335 high dose DRUG

BI 201335 high dose; BI 201335 or Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy caucasian males and females, 18 to 50 years of age
• Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
• Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
• Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug before enrolment in the study or during the study
• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
• Participation in another trial with an investigational drug (≤ 30 days prior to administration or during the trial)
• Heavy smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
• Any deviation of a laboratory value that is considered to be of clinical relevance

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

faldaprevir; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2008
• Primary Completion: October 1, 2008
• Last Updated: July 18, 2014

Record last verified: 2014-07