Assessment of Electrophysiological Effects of Dabigatran Etexilate as Single Dose on the QT Interval in Healthy Female and Male Subjects.

NCT02170987 | Completed Phase 1

• 1 other identifier: 1160.54
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate if dabigatran has a clinically relevant impact on the cardiac electrophysiology that is manifest as prolongation in QT-interval.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean time-matched QTc Interval

  at 1.5, 2, and 3 hours following administration

Secondary Outcomes (2)

• Mean of the QTcI values of all ECGs

  from 1 to 6 hours following administration

• Change from baseline of the QTcI

  from 1 to 24 hours following administration

Study Arms (4)

Dabigatran etexilate low

EXPERIMENTAL

Drug: Dabigatran etexilate low

Dabigatran etexilate high

EXPERIMENTAL

Drug: Dabigatran etexilate high

Placebo to dabigatran etexilate

PLACEBO COMPARATOR

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin

Interventions

Dabigatran etexilate low DRUG

Dabigatran etexilate low

Dabigatran etexilate high DRUG

Dabigatran etexilate high

Moxifloxacin DRUG

Moxifloxacin

Placebo DRUG

Placebo to dabigatran etexilate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy female (at least 1/3) and male (at least 1/3) volunteers as determined by the results of screening according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
• Age \>= 18 and Age \<= 65 years
• BMI \>= 20.0 and BMI \<=29.9 kg/m2 (Body Mass Index)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

You may not qualify if:

• Any finding of the medical examination (including BP, pulse rate (PR) and ECG) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• 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 relevant orthostatic hypotension, fainting spells or blackouts
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
• 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 prior to administration or during the trial
• Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
• Participation in another trial with an investigational drug within two months prior to administration or during the trial
• Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 60 g/day)
• Drug abuse
• Blood donation (more than 100 mL within four weeks prior to administration or during the trial)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

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: June 20, 2014
• First Posted: June 23, 2014
• Study Start: March 1, 2006
• Primary Completion: May 1, 2006
• Last Updated: June 23, 2014

Record last verified: 2014-06