Hepatitus C
Conditions
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: -Participant must have a body mass index (BMI: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included, and a body weight not less than 50.0 kg. -Participants must sign an ICF indicating that he or she understands the purpose of, and the procedures required for, the study and is willing to participate in the study. -Participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol -Participants must be healthy on the basis of physical examination, medical history, vital signs, and 12lead ECG performed at screening. If there are abnormalities, the subject 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 subject's source documents and initialed by the investigator. -Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the biochemistry panel, hematology, or urinalysis are outside the normal reference ranges, the subject may be included (except for those listed in the exclusion criteria) only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: -Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 60 milliletter(ml)/min* 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. -Participants has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the wellbeing) or that could prevent, limit, or confound the protocolspecified assessments. -Participants with one or more of the following laboratory abnormalities at screening as defined by the World Health Organization (WHO) Toxicity Grading Scale: 1) Serum creatinine grade 1 or greater (>=1.1 x ULN). 2) Pancreatic amylase or lipase grade 2 or greater (>1.5 x ULN). 3) Hemoglobin grade 1 or greater (=1.25 x ULN). 7) Total bilirubin grade 1 or greater (>=1.1 x ULN), unless the subject is diagnosed with Gilbert*s disease. 8) Hypokalemia grade 2 or greater (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the relative oral bioavailability of SMV, ODV, and AL-335 when administered as different concept FDCs compared to the single agents when administered together, all under fed conditions in healthy subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events. | — |
Countries
Netherlands
Outcome results
None listed