A Pharmacokinetic Interaction Study Between Odalasvir, Gi... | NCT02945020

ID	Type	Description	Link
64294178HPC1003	Other Identifier	Janssen Research & Development, LLC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dabigatran etexilate mesylate+Odalasvir+Simeprevir	Experimental	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 Drug: Odalasvir (ODV) Drug: Simeprevir (SMV)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dabigatran etexilate mesylate	Drug	Participants will receive dabigatran etexilate mesylate 75 mg, orally.	Dabigatran etexilate mesylate+Odalasvir+Simeprevir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Analyte Concentration (Cmax) of Dabigatran	Cmax is the maximum observed analyte concentration.	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)
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Dabigatran	The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.	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)
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Dabigatran	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.	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)

Measure	Description	Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability		Baseline, up to follow-up (Approximately 43 days)

Eligibility Module

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

ID	Term
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D013449	Sulfonamides
D013450	Sulfones
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006575	Heterocyclic Compounds, 3-Ring