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Trial record 41 of 333 for:    DABIGATRAN

A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02945020
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), as a single agent or in combination with simeprevir (SMV), on the single-dose pharmacokinetics of dabigatran etexilate in healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dabigatran etexilate mesylate Drug: Odalasvir (ODV) Drug: Simeprevir (SMV) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Open-label, Sequential Study to Investigate the Pharmacokinetic Interaction Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Subjects
Actual Study Start Date : November 10, 2016
Actual Primary Completion Date : January 9, 2017
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dabigatran etexilate mesylate+Odalasvir+Simeprevir
All participants will receive study medications in a fixed sequential order as: a single dose of dabigatran etexilate mesylate 75 milligram (mg) on Days 1, 17 and 26; Odalasvir (ODV) 25 mg once daily from Day 4 to 28; Simeprevir (SMV) 75 mg once daily from Day 20 to 28. The study drugs will be taken orally.
Drug: Dabigatran etexilate mesylate
Participants will receive dabigatran etexilate mesylate 75 mg, orally.

Drug: Odalasvir (ODV)
Participants will receive ODV 25 mg, orally.

Drug: Simeprevir (SMV)
Participants will receive SMV 75 mg, orally.




Primary Outcome Measures :
  1. Maximum Observed Analyte Concentration (Cmax) of Dabigatran [ Time Frame: Day 1, 17 and 26 (predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, and 72 hours post dose) ]
    Cmax is the maximum observed analyte concentration.

  2. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Dabigatran [ Time Frame: Day 1, 17 and 26 (predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, and 72 hours post dose) ]
    The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Dabigatran [ Time Frame: Day 1, 17 and 26 (predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, and 72 hours post dose) ]
    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Baseline, up to follow-up (Approximately 43 days) ]


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant must have a body mass index (BMI: weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 32.0 kilogram per square meter (kg/m^2), extremes included, and a body weight not less than 50.0 kg
  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
  • Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
  • Female participant, except if postmenopausal, must have a negative highly sensitive serum beta human chorionic gonadotropin at screening
  • Participant must be non-smoker for at least 6 months prior to the first study drug administration

Exclusion Criteria:

  • Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 90 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula or below 90 mL/min/1.73 square meter (m^2) for estimated glomerular filtration rate [eGFR] according to the Chronic Kidney Disease Epidemiology Collaboration equation [CKD-EPI]), significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
  • Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the particiapant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
  • Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV), simeprevir (SMV) or dabigatran etexilate mesylate or their excipients
  • Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945020


Locations
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United States, Arizona
Tempe, Arizona, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02945020     History of Changes
Other Study ID Numbers: CR108164
64294178HPC1003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dabigatran
Simeprevir
Odalasvir
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antiviral Agents
Anti-Infective Agents