Safety and Pharmacokinetics of Quinidine Alone and in Combination With Dabigatran Etexilate

NCT02171624 | Completed Phase 1

• 1 other identifier: 1160.90
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Open-label, two-way crossover design with a quinidine sulfate run-in period followed by a randomised sequence of dabigatran etexilate plus quinidine sulfate or dabigatran etexilate alone to evaluate the safety of co-administration of dabigatran etexilate and quinidine. and the pharmacokinetic interaction between quinidine and dabigatran etexilate.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Differences between treatments in systolic blood pressure profiles (using area under the BP-time curve)

  -0:15 before, and every 15 minutes for 2 hours post-dose, 3, 4 and 12 hours post dose

• Incidence of symptomatic hypotension

  -0:15 before, and every 15 minutes for 2 hours post-dose, 3, 4 and 12 hours post dose

Secondary Outcomes (22)

• Area under the effect curve (AUEC) for activated partial thromboplastin time (aPTT), thrombin time (TT) and ecarin clotting time (ECT)

  up to 48 hours after last dose

• Maximum effect ratio (ERmax) for activated partial thromboplastin time (aPTT), thrombin time (TT) and ecarin clotting time (ECT)

  up to 48 hours after last dose

• Occurrence of Adverse Events

  up to day 26

• Abnormal findings in physical examination

  up to day 26

• Changes from baseline in Vital Signs (Blood Pressure (BP), Heart Rate (HR))

  up to day 26

Study Arms (2)

dabigatran etexilate

EXPERIMENTAL

quinidine run-in, followed by dabigatran+quinine and dabigatran alone in randomized order

Drug: dabigatran etexilate; Drug: quinidine

quinidine

EXPERIMENTAL

quinidine run-in, followed by dabigatran+quinine and dabigatran alone in randomized order

Drug: dabigatran etexilate; Drug: quinidine

Interventions

dabigatran etexilate DRUG

dabigatran etexilate; quinidine

quinidine DRUG

dabigatran etexilate; quinidine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects
• Age ≥18 and Age ≤55 years
• Body Mass Index (BMI) ≥18.5 and BMI \<30 kg/m2
• 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 Blood Pressure (BP), Pulse Rate (PR) and Electrocardiogram (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
• Surgery of the gastrointestinal tract (except appendectomy)
• 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 or that prolong the QT/QTc interval 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 thirty days prior to administration or during the trial
• Inability to refrain from smoking on trial days Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
• 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

Dabigatran; Quinidine

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: March 1, 2009
• Primary Completion: April 1, 2009
• Last Updated: June 24, 2014

Record last verified: 2014-06