A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:1/12/2017
Start Date:September 2016
End Date:March 2017
Contact:Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email:JNJ.CT@sylogent.com

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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

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
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Tempe, AZ
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