NCT02171546

Brief Summary

Part 1: To investigate the effect of quinidine, a P-glycoprotein (P-gp) probe inhibitor on the bioavailability of dabigatran etexilate, Part 2: To determine the effect of quinidine on the bioavailability of fexofenadine, a probe substrate for P-gp

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

2 months

First QC Date

June 20, 2014

Last Update Submit

June 20, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • AUCτ,ss (area under the concentration-time curve of dabigatran in plasma at steady state over one dosing interval)

    Before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00 and 12:00 hours after dosing on day 3

  • Cmax,ss (maximum concentration of dabigatran in plasma at steady state)

    Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3

  • AUC0-∞ (area under the concentration-time curve of fexofenadine in plasma over the time interval from 0 to infinity)

    Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1

  • Cmax (maximum measured concentration of fexofenadine in plasma)

    Before dose, 0:30, 1:00,1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on day 1

Secondary Outcomes (20)

  • AUC0-tz,ss (area under the concentration-time curve of dabigatran in plasma from the time point 0 after the last dose at steady state to the last quantifiable dabigatran plasma concentration within the uniform dosing interval τ)

    0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3

  • tz,ss (time of last measurable concentration of dabigatran in plasma within the dosing interval τ at steady state)

    0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3

  • tmax,ss (time from last dosing to the maximum concentration of dabigatran in plasma at steady state)

    0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24 and 48 hours after dosing on day 3

  • CL/Fss (apparent clearance of dabigatran in the plasma at steady state)

    Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3

  • Cmin,ss (minimum measured concentration of dabigatran in plasma at steady state)

    Before dose on day 1, day 2, before dose, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 and 48:00 hours after dosing on Day 3

  • +15 more secondary outcomes

Study Arms (4)

Dabigatran etexilate capsules

ACTIVE COMPARATOR
Drug: Dabigatran etexilate capsules

Dabigatran etexilate capsules and quinidine sulfate tablets

EXPERIMENTAL
Drug: Dabigatran etexilate capsulesDrug: Quinidine sulfate tablets

Fexofenadine tablets

ACTIVE COMPARATOR
Drug: Fexofenadine tablets

Fexofenadine and quinidine sulfate tablets

EXPERIMENTAL
Drug: Quinidine sulfate tabletsDrug: Fexofenadine tablets

Interventions

Dabigatran etexilate capsulesDRUG
Dabigatran etexilate capsulesDabigatran etexilate capsules and quinidine sulfate tablets
Quinidine sulfate tabletsDRUG
Dabigatran etexilate capsules and quinidine sulfate tabletsFexofenadine and quinidine sulfate tablets
Fexofenadine tabletsDRUG
Fexofenadine and quinidine sulfate tabletsFexofenadine tablets

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests ;
  • 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;
  • If female of child-bearing potential, not be pregnant or breast feeding, nor plan to become pregnant for the duration of the study and for 2 months after receiving the last dose of study drug, and have a negative serum pregnancy test within 14 days of treatment, and prior to dosing;
  • Females of child-bearing potential willing to use adequate contraception, defined as the use of hormonal (oral, injectable or implantable) or barrier method contraceptives, intrauterine device and agree to use the same method of contraception for at least 2 months after drug administration. Women who have undergone a total hysterectomy, have a history of bilateral tubal ligation or are at least 2 years post-menopausal are not considered to be of child-bearing potential.

You may not qualify if:

  • Any finding of the medical examination (including BP, 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;
  • 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 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DabigatranQuinidinefexofenadine

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCinchona AlkaloidsAlkaloidsQuinuclidinesHeterocyclic Compounds, Bridged-RingQuinolines

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

November 1, 2007

Primary Completion

January 1, 2008

Last Updated

June 24, 2014

Record last verified: 2014-06