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

NCT02889367 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10816364294178HPC1002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The Relationship Between the Plasma Concentrations of Odalasvir and Changes in the QT/QTc Interval Using Exposure-response (ER) Analysis

  A linear mixed-effects model will assess the effect of dose and treatment on the change from baseline in QTc over time.

  Baseline up to Day 4

Secondary Outcomes (5)

• Maximum Plasma Concentration (Cmax) of Odalasvir

  0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of Odalasvir

  0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Odalasvir

  0 hour (pre-dose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 30, 36, 48, 72 and 120 hours post-dose on Day 1

• PR Interval Changes and the Relationship Between the Plasma Concentrations of Odalasvir and PR Interval Changes Using ER Analysis

  Baseline up to Day 4

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  up to Day 65

Study Arms (3)

Treatment A

EXPERIMENTAL

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

Drug: Odalasvir 100 mg; Drug: Placebo

Treatment B

EXPERIMENTAL

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

Drug: Placebo; Drug: Odalasvir 500 mg

Treatment C

EXPERIMENTAL

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.

Drug: Placebo; Drug: Odalasvir (Up to maximum 1000 mg)

Interventions

Odalasvir 100 mg DRUG

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

Treatment A

Placebo DRUG

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

Treatment A; Treatment B; Treatment C

Odalasvir 500 mg DRUG

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

Treatment B

Odalasvir (Up to maximum 1000 mg) DRUG

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

Treatment C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

MeSH Terms

Interventions

odalasvir

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 5, 2016
• Study Start: September 12, 2016
• Primary Completion: March 4, 2017
• Study Completion: March 4, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)