Clinical trial NCT02945020 (phase 1, status: completed)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: dabigatran etexilate mesylate, odalasvir (odv), simeprevir (smv)
SMILES: CCCCCCOC(=O)\N=C(\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1, CN(C)CC(C1=CC=C(O)C=C1)C1(O)CCCCC1, [H]\C1=C([H])\[C@]2([H])C[C@]2(N=C(O)[C@]2([H])C[C@]([H])(C[C@@]2([H])C(=O)N(C)CCCC1)OC1=C2C=CC(OC)=C(C)C2=NC(=C1)C1=NC(=CS1)C(C)C)C(O)=NS(=O)(=O)C1CC1
Eligibility 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