The purpose of this study is to determine the relationship between the plasma concentrations
of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate)
using exposure-response (ER) analysis.
Drug: Odalasvir 100 mg
Drug: Odalasvir 500 mg
Drug: Odalasvir (Up to maximum 1000 mg)
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Locations near you
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Full eligibility criteria for NCT02889367
Ages eligible for Study
18 Years to 50 Years
Genders eligible for Study
Accepts Healthy Volunteers
Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
Participant must be healthy on the basis of physical examination, medical history, and vital signs performed at screening
Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
Participant must have normal 12-lead electrocardiogram (ECG) and echocardiogram and must be healthy on the basis of clinical laboratory tests performed at screening
Participant must be nonsmoker for at least 6 months prior to study drug administration
Participant with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardia, and heart blocks
Participant with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
Participant with a past history of: Sick sinus syndrome, Cardiac arrhythmia (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary, Risk factors associated with Torsade de Pointes (TdP) such as hypokalemia, Family history of short/long QT syndrome, Sudden unexplained death
(including sudden infant death syndrome) in a first‑degree relative (that is, sibling, offspring, or biological parent)
Participant with any skin condition likely to interfere with ECG electrode placement or adhesion
Participant with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
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 received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days or within a period less than 10 times the drug's half-life, whichever is longer, before the planned administration of study drug, or is currently enrolled in an investigational study
Participant has a history of human immunodeficiency virus (HIV)-1 or HIV-2 infection positive, or tests positive for HIV-1 or HIV-2 at screening
All locations for NCT02889367
Tempe, Arizona, United States
View full eligibility
Tris trial is registered with FDA with number: NCT02889367. The sponsor of the trial is Janssen Research & Development, LLC and it is looking for 60 volunteers for the current phase.
Official trial title: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Tablet Formulation Under Fed Conditions in Healthy Subjects
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