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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

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Odalasvir 100 mg

Placebo

Odalasvir 500 mg

Odalasvir (Up to maximum 1000 mg)

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Treatment A

Treatment B

Treatment C

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) of Odalasvir

Cmax is the maximum observed analyte concentration.

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

AUC(0-last) is the area under the plasma concentration-time curve from time zero to the last quantifiable time.

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

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

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

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

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

Full Information

NCT ID

NCT02889367

First Posted

August 31, 2016

Last Updated

April 7, 2017

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT02889367

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 12, 2016 (Actual)

Primary Completion Date

March 4, 2017 (Actual)

Study Completion Date

March 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment B

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment C

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Odalasvir 100 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Odalasvir 500 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Odalasvir (Up to maximum 1000 mg)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline up to Day 4

Secondary Outcome Measure Information:

Title

Maximum Plasma Concentration (Cmax) of Odalasvir

Description

Cmax is the maximum observed analyte concentration.

Time Frame

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

Title

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

Description

AUC(0-last) is the area under the plasma concentration-time curve from time zero to the last quantifiable time.

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

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

Time Frame

Baseline up to Day 4

Title

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

Time Frame

up to Day 65

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

City

Tempe

State/Province

Arizona

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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