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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:19 - 55
Updated:6/9/2017
Start Date:November 10, 2016
End Date:January 20, 2017

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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

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.


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
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