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

NCT ID: NCT02889367

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-12
• Study Completion Date: 2017-03-04

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Treatment A

Participants will receive odalasvir 100 milligram (mg) or odalasvir matching placebo once on Day 1.

Group Type: EXPERIMENTAL

Odalasvir 100 mg

Intervention Type: DRUG

Participants will receive odalasvir 2\*50 mg tablet, orally once on Day 1.

Placebo

Intervention Type: DRUG

Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.

Treatment B

Participants will receive odalasvir 500 mg or odalasvir matching placebo once on Day 1.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.

Odalasvir 500 mg

Intervention Type: DRUG

Participants will receive odalasvir 10\*50 mg tablet, orally once on Day 1.

Treatment C

Participants will receive odalasvir (dose to be determined based on pharmacokinetic data from treatment A and B but no more than 1000 mg) or odalasvir matching placebo once on Day 1.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.

Odalasvir (Up to maximum 1000 mg)

Intervention Type: DRUG

Participants will receive odalasvir to be decided up to maximum of 20\*50 mg tablet, orally once on Day 1.

Interventions

Odalasvir 100 mg

Participants will receive odalasvir 2\*50 mg tablet, orally once on Day 1.

Intervention Type: DRUG

Placebo

Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.

Intervention Type: DRUG

Odalasvir 500 mg

Participants will receive odalasvir 10\*50 mg tablet, orally once on Day 1.

Intervention Type: DRUG

Odalasvir (Up to maximum 1000 mg)

Participants will receive odalasvir to be decided up to maximum of 20\*50 mg tablet, orally once on Day 1.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Tempe, Arizona, United States

Countries

United States

Other Identifiers

64294178HPC1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR108163

Identifier Type: -

Identifier Source: org_study_id