Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects

NCT02183467 | Completed Phase 1

• 1 other identifier: 1218.32
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Assessment of the effect of BI 1356 or Placebo on prolongation of the QT interval

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change from baseline of the QTcI interval (individually heart rate-corrected QT interval length)

  Pre-dose and 1 to 4 hours following administration

Secondary Outcomes (2)

• Mean of the QTcI change from baseline of all electrocardiograms (ECGs) taken from 1 hour to 24 hours after dosing

  up to 24 hours following administration

• Change from mean baseline of the QTcI at any point in time between 1 and 24 hours after dosing

  up to 24 hours following administration

Study Arms (4)

BI 1356, low dose

EXPERIMENTAL

Drug: BI 1356, low dose

BI 1356, high dose

EXPERIMENTAL

Drug: BI 1356, high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Interventions

BI 1356, low dose DRUG

BI 1356, low dose

BI 1356, high dose DRUG

BI 1356, high dose

Placebo DRUG

Placebo

Moxifloxacin DRUG

Also known as: Avalox®

Moxifloxacin

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females, 21 to 50 years of age
• Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2
• 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 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 ten 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 (≤ 60 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

Linagliptin; Moxifloxacin

Intervention Hierarchy (Ancestors)

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

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 4, 2014
• First Posted: July 8, 2014
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Last Updated: July 8, 2014

Record last verified: 2014-07