A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03155893

Collaborator

(none)

Enrollment

Location

Arms

5.5

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to assess the effect of a single supratherapeutic dose of AL-335 administered on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo on QT/QT interval corrected for heart rate (QTc) interval changes, using intersection-union test (IUT) analysis (Panel 1); to assess the effect of ODV on QT/QTc and PR interval changes after multiple supratherapeutic doses of ODV using an exposure-response (ER) approach (Panel 2); and to assess the effect of multiple supratherapeutic doses of ODV on echocardiographic left ventricular ejection fraction (LVEF) (Panel 2) in healthy participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ODV Placebo (Matching 25 mg ODV) Drug: ODV Placebo (Matching 200 mg ODV) Drug: ODV Placebo (Matching 125 mg ODV) Drug: ODV Placebo (Matching 100 mg ODV) Drug: SMV Placebo (Matching 150 mg SMV) Drug: AL-335 Placebo (matching 1200 mg AL-335) Drug: Moxifloxacin Placebo (matching 400 mg moxifloxacin) Drug: ODV 25 mg Drug: ODV 200 mg Drug: ODV 125 mg Drug: ODV 100 mg Drug: SMV 150 mg Drug: AL-335 1200 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

A Randomized, Double-blind, Double-dummy, Placebo- and Positive-controlled Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Subjects

Actual Study Start Date :

May 12, 2017

Actual Primary Completion Date :

Oct 27, 2017

Actual Study Completion Date :

Oct 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Panel 1: Treatment A Participants will receive odalasvir (ODV) placebo (matching 25 milligram [mg] ODV [125 mg tablet]) and simeprevir (SMV) placebo (matching 150 mg SMV [275 mg capsules]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram [mg] AL-335 [3400 mg tablets]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin [1400 mg capsule]) as a single dose on Day 1, 15 and 16 along with moxifloxacin 400 mg (1*400 mg capsule) single dose on Day 2 orally under fed conditions.	Drug: ODV Placebo (Matching 25 mg ODV) Participants will receive ODV placebo (matching 25 [mg] ODV [125 mg tablet]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1. Drug: SMV Placebo (Matching 150 mg SMV)* Participants will receive SMV Placebo (matching 150 mg SMV [275 mg capsules]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C. Drug: AL-335 Placebo (matching 1200 mg AL-335)* Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 [3400 mg tablets]) administered orally on Day 15 in Treatment A and B. Drug: Moxifloxacin Placebo (matching 400 mg moxifloxacin)* Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin [1*400 mg capsule]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C.
Experimental: Panel 1: Treatment B Participants will receive odalasvir (ODV) placebo (matching 25 milligram [mg] ODV [125 mg tablet]) and simeprevir (SMV) placebo (matching 150 mg SMV [275 mg capsules]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram [mg] AL-335 [3400 mg tablets]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin [1400 mg capsule]) as a single dose on Day 1, 2 and 15 along with moxifloxacin 400 mg (1*400 mg capsule) single dose on Day 16 orally under fed conditions.	Drug: ODV Placebo (Matching 25 mg ODV) Participants will receive ODV placebo (matching 25 [mg] ODV [125 mg tablet]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1. Drug: SMV Placebo (Matching 150 mg SMV)* Participants will receive SMV Placebo (matching 150 mg SMV [275 mg capsules]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C. Drug: AL-335 Placebo (matching 1200 mg AL-335)* Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 [3400 mg tablets]) administered orally on Day 15 in Treatment A and B. Drug: Moxifloxacin Placebo (matching 400 mg moxifloxacin)* Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin [1*400 mg capsule]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C.
Experimental: Panel 1: Treatment C Participants will receive odalasvir (ODV) placebo (matching 25 milligram [mg] ODV [125 mg tablet]) and simeprevir (SMV) placebo (matching 150 mg SMV [275 mg capsules]) once daily on Day 1 and moxifloxacin placebo (matching 400 mg moxifloxacin [1400 mg capsule]) as a single dose on Day 1, 2, 15 and 16 along with ODV 25 mg (125 mg tablet) and SMV 150 mg (275 mg capsule) once daily on Day 2 to 16 and AL-335 1200 mg (3400 mg tablet) single dose on Day 15 orally under fed conditions.	Drug: ODV Placebo (Matching 25 mg ODV) Participants will receive ODV placebo (matching 25 [mg] ODV [125 mg tablet]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1. Drug: SMV Placebo (Matching 150 mg SMV)* Participants will receive SMV Placebo (matching 150 mg SMV [275 mg capsules]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C. Drug: Moxifloxacin Placebo (matching 400 mg moxifloxacin)* Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin [1400 mg capsule]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C. Drug: ODV 25 mg* Participants will receive ODV 25 mg orally once daily administered on Days 2 to 16 in Treatment C. Drug: SMV 150 mg Participants will receive SMV 150 mg (275 mg capsules) orally once daily administered on Days 2 to 16 in Treatment C. Drug: AL-335 1200 mg* Participants will receive a single oral dose of AL-335 1200 mg (3*400 mg tablets) administered on Day 15 in Treatment C.
Placebo Comparator: Panel 2: Treatment E Participants will receive ODV placebo (matching 200 mg ODV [450 mg tablets]) on Days 1 and 2; ODV placebo (matching 125 mg ODV [250 mg tablets + 125 mg tablets]) on Days 3 to 7; and ODV placebo (matching 100 mg ODV [250 mg tablets] on Days 8 to 14, orally once daily under fed conditions.	Drug: ODV Placebo (Matching 200 mg ODV) Participants will receive ODV placebo (matching 200 mg ODV [450 mg tablets]) on Days 1 and 2 in Treatment E. Drug: ODV Placebo (Matching 125 mg ODV)* Participants will receive ODV placebo (matching 125 mg ODV [250 mg tablets + 125 mg tablets]) orally once daily on Days 3 to 7 in Treatment E. Drug: ODV Placebo (Matching 100 mg ODV) Participants will receive ODV placebo (matching 100 mg ODV [2*50 mg tablets] orally once daily on Days 8 to 14 in Treatment E.
Experimental: Panel 2: Treatment F Participants will receive ODV 200 mg (450 mg tablets) on Days 1 and 2; ODV 125 mg (250 mg tablets + 125 mg tablets) on Days 3 to 7, and ODV 100 mg (250 mg tablets) on Days 8 to 14, orally once daily under fed conditions.	Drug: ODV 200 mg Participants will receive ODV 200 mg (450 mg tablets) orally once daily will be administered on Days 1 and 2 in Treatment F. Drug: ODV 125 mg* Participants will receive ODV 125 mg (250 mg tablets + 125 mg tablets) once daily administered on Days 3 to 7 in Treatment F. Drug: ODV 100 mg Participants will receive ODV 100 mg (2*50 mg tablets) orally once daily administered on Days 8 to 14 in Treatment F.

Outcome Measures

Primary Outcome Measures

Panel 1:Effect of AL-335 Single Supratherapeutic Dose on QT/QTc Interval Change on top of Multiple Doses of ODV and SMV Vs. Placebo Using IUT Analysis at Day 16 [Baseline (Day 1), Day 15]
Intersection-union test (IUT) analysis will be performed to evaluate the effect of AL-335 on QT/QTc interval changes after a single supratherapeutic dose of AL-335 on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo.
Panel 2: Effect of ODV on QT/QTc Interval Change From Baseline After Multiple Supratherapeutic Doses of ODV Using ER Approach at Day 14 [Baseline (Day -3), Day 14]
Exposure-response (ER) analysis will be performed to evaluate the effect of ODV on QT/QTc interval changes after multiple supratherapeutic doses of ODV.
Panel 2: Effect of ODV on QT/QTc Interval Change From Baseline After Multiple Supratherapeutic Doses of ODV Using ER Approach at Day 15 [Baseline (Day -3), Day 15]
ER analysis will be performed to evaluate the effect of ODV on QT/QTc interval changes after multiple supratherapeutic doses of ODV.
Panel 2: Effect of ODV on QT/QTc Interval Change From Baseline After Multiple Supratherapeutic Doses of ODV Using ER Approach at Day 16 [Baseline (Day -3), Day 16]
ER analysis will be performed to evaluate the effect of ODV on QT/QTc interval changes after multiple supratherapeutic doses of ODV.
Panel 2: Effect of ODV on PR Interval Change From Baseline After Multiple Supratherapeutic Doses of ODV Using ER Approach at Day 14 [Baseline (Day -3), Day 14]
ER analysis will be performed to evaluate the effect of ODV on PR interval changes after multiple supratherapeutic doses of ODV.
Panel 2: Effect of ODV on PR Interval Change From Baseline After Multiple Supratherapeutic Doses of ODV Using ER Approach at Day 15 [Baseline (Day -3), Day 15]
ER analysis will be performed to evaluate the effect of ODV on PR interval changes after multiple supratherapeutic doses of ODV.
Panel 2: Effect of ODV on PR Interval Change From Baseline After Multiple Supratherapeutic Doses of ODV Using ER Approach at Day 16 [Baseline (Day -3), Day 16]
ER analysis will be performed to evaluate the effect of ODV on PR interval changes after multiple supratherapeutic doses of ODV.
Panel 2: Effect of Multiple Supratherapeutic Doses of ODV on Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Day 10 [Baseline (Day -2 and -1), Day 10]
Echocardiogram measurements will be performed to evaluate the effect of multiple supratherapeutic doses of ODV on change in echocardiographic LVEF. The baseline for echocardiographic LVEF will be the average of Days -2 and -1.
Panel 2: Effect of Multiple Supratherapeutic Doses of ODV on Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Day 14 [Baseline (Day -2 and -1), Day 14]
Echocardiogram measurements will be performed to evaluate the effect of multiple supratherapeutic doses of ODV on change in echocardiographic LVEF. The baseline for echocardiographic LVEF will be the average of Days -2 and -1.
Panel 2: Effect of Multiple Supratherapeutic Doses of ODV on Change From Baseline in Echocardiographic Left Ventricular Ejection Fraction (LVEF) at Day 28 [Baseline (Day -2 and -1), Day 28]
Echocardiogram measurements will be performed to evaluate the effect of multiple supratherapeutic doses of ODV on change in echocardiographic LVEF. The baseline for echocardiographic LVEF will be the average of Days -2 and -1.

Secondary Outcome Measures

Panel 1: Maximum Observed Analyte Concentration (Cmax) of AL-335 and its 2 metabolites ALS-022399 and ALS-022227 [Panel 1, Day 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
The Cmax is the maximum observed analyte concentration.
Panel 1: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of AL-335 and its 2 metabolites ALS-022399 and ALS-022227 [Panel 1, Day 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Panel 1: Area Under the Analyte Concentration-time Curve From Time 0 to 24 Hours Postdose (AUC24) of AL-335 and its 2 metabolites ALS-022399 and ALS-022227 [Panel 1, Day 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
AUC24 is defined as area under the analyte concentration-time curve from time 0 to 24 hours postdose.
Panel 1: Area Under the Analyte Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast) of AL-335 and its 2 metabolites ALS-022399 and ALS-022227 [Panel 1, Day 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
AUClast is defined as area under the analyte concentration-time curve from time 0 to the time of the last measurable (non-below quantification limit [BQL]) concentration.
Panel 1: Apparent Terminal Elimination Half-life (t1/2term) of AL-335 and its 2 metabolites ALS-022399 and ALS-022227 [Panel 1, Day 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
Apparent terminal elimination half-life is defined as 0.693/lambda(z).
Panel 1: Apparent Terminal Elimination Rate Constant (Lambda[z]) of AL-335 and its 2 metabolites ALS-022399 and ALS-022227 [Panel 1, Day 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
Lambda(z) is defined as apparent terminal elimination rate constant, determined by linear regression using the terminal log-linear phase of the log transformed concentration versus time curve.
Panel 1: Area Under the Analyte Concentration-time Curve From Time 0 to Infinite Time (AUC[0-infinity]) of AL-335 and its 2 metabolites ALS-022399 and ALS-022227 [Panel 1, Day 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
The AUC (0-infinity) is the area under the analyte concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(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.
Panel 1 and 2: Maximum Observed Analyte Concentration (Cmax) of ODV [Panel 1, Days 14 and 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose; Panel 2, Day 14: predose, 1, 3, 4, 5, 6, 7, 8, 10, 12, 24, 28, 32, 36, 48, 52, 56, 60, and 72 hours postdose]
The Cmax is the maximum observed analyte concentration.
Panel 1 and 2: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of ODV [Panel 1, Days 14 and 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose; Panel 2, Day 14: predose, 1, 3, 4, 5, 6, 7, 8, 10, 12, 24, 28, 32, 36, 48, 52, 56, 60, and 72 hours postdose]
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Panel 1 and 2: Minimum Observed Analyte Concentration (Cmin) of ODV [Panel 1, Days 14 and 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose; Panel 2, Day 14: predose, 1, 3, 4, 5, 6, 7, 8, 10, 12, 24, 28, 32, 36, 48, 52, 56, 60, and 72 hours postdose]
The Cmin is a minimum observed analyte concentration.
Panel 1 and 2: Observed Analyte Concentration Just Prior to the Beginning of a Dosing Interval (Ctrough) of ODV [Panel 1: Predose on Days 14 and 15; Panel 2: Predose on Day 14]
The Ctrough is the observed analyte concentration just prior to the beginning of a dosing interval.
Panel 1 and 2: Area Under the Analyte Concentration-time Curve From Time 0 to 24 hours Postdose (AUC24) of ODV [Panel 1, Days 14 and 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose; Panel 2, Day 14: predose, 1, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose]
AUC24 is defined as area under the analyte concentration-time curve from time 0 to 24 hours postdose.
Panel 2: Observed Analyte Concentration of ODV [Panel 2, Days 10 and 14: 6 and 8 hours postdose; Day 28: 6 and 8 hours]
Observed analyte concentration of ODV will be assessed on Days 10, 14 and 28.
Panel 1: Maximum Observed Analyte Concentration (Cmax) of SMV [Panel 1, Days 14 and 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
The Cmax is the maximum observed analyte concentration.
Panel 1: Time to Reach the Maximum Observed Analyte Concentration (Tmax) of SMV [Panel 1, Days 14 and 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
The tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Panel 1: Minimum Observed Analyte Concentration (Cmin) of SMV [Panel 1, Days 14 and 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
The Cmin is the minimum observed analyte concentration.
Panel 1: Observed Analyte Concentration Just Prior to the Beginning of a Dosing Interval (Ctrough) of SMV [Panel 1: Predose on Days 14 and 15]
The Ctrough is the observed analyte concentration just prior to the beginning of a dosing interval.
Panel 1: Area Under the Analyte Concentration-time Curve From Time 0 to 24 hours Postdose (AUC24) of SMV [Panel 1, Days 14 and 15: Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 hours postdose]
AUC24 is defined as area under the analyte concentration-time curve from time 0 to 24 hours postdose.
Panel 1 and 2: Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Up to Day 49 (Panel 1) and Day 66 (Panel 2)]
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Panel 1: Effect of Moxifloxacin on the QT/QTc Interval Change From Baseline at Day 2 and 16 [Baseline (Day 1), Days 2 and 16]
The effect of moxifloxacin on the QT/QTc Interval changes will be assessed for assay sensitivity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants must sign and date an informed consent form (ICF) indicating that he or she understands the purpose of, and the procedures required for, the study and is willing to participate in the study
Participant must be healthy on the basis of physical examination, medical history, vital signs, and laboratory tests performed at screening
Participant must have a blood pressure (supine after at least 5 minutes rest) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
Participant must have a 12-lead electrocardiogram (ECG) (based on the mean value of triplicate ECG parameters) consistent with normal cardiac conduction and function at screening
Participant must have an echocardiogram at screening with left ventricular ejection fraction (LVEF) greater than or equal to (>=)55 percent (%). Participant should not have any other echocardiogram finding suggestive of clinically relevant cardiomyopathy
Female participant must have a negative highly sensitive urine pregnancy test at Day -2 (Panel 1) or Day -4 (Panel 2)

Exclusion Criteria:

Participant has a history of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, constipation, or gastrointestinal surgery that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
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 corrected QT (QTc) measurements
Participant with a past history of sick sinus syndrome, heart arrhythmias (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 electrocardiogram (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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Tempe	Arizona	United States	85283

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen Research & Development, LLC

ClinicalTrials.gov Identifier:

NCT03155893

Other Study ID Numbers:

CR108332
64294178HPC1012

First Posted:

May 16, 2017

Last Update Posted:

Nov 14, 2017

Last Verified:

Nov 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Moxifloxacin

Adafosbuvir

Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Nov 14, 2017

Arm	Intervention/Treatment
Experimental: Panel 1: Treatment A Participants will receive odalasvir (ODV) placebo (matching 25 milligram [mg] ODV [125 mg tablet]) and simeprevir (SMV) placebo (matching 150 mg SMV [275 mg capsules]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram [mg] AL-335 [3400 mg tablets]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin [1400 mg capsule]) as a single dose on Day 1, 15 and 16 along with moxifloxacin 400 mg (1*400 mg capsule) single dose on Day 2 orally under fed conditions.	Drug: ODV Placebo (Matching 25 mg ODV) Participants will receive ODV placebo (matching 25 [mg] ODV [125 mg tablet]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1. Drug: SMV Placebo (Matching 150 mg SMV)* Participants will receive SMV Placebo (matching 150 mg SMV [275 mg capsules]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C. Drug: AL-335 Placebo (matching 1200 mg AL-335)* Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 [3400 mg tablets]) administered orally on Day 15 in Treatment A and B. Drug: Moxifloxacin Placebo (matching 400 mg moxifloxacin)* Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin [1*400 mg capsule]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C.
Experimental: Panel 1: Treatment B Participants will receive odalasvir (ODV) placebo (matching 25 milligram [mg] ODV [125 mg tablet]) and simeprevir (SMV) placebo (matching 150 mg SMV [275 mg capsules]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram [mg] AL-335 [3400 mg tablets]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin [1400 mg capsule]) as a single dose on Day 1, 2 and 15 along with moxifloxacin 400 mg (1*400 mg capsule) single dose on Day 16 orally under fed conditions.	Drug: ODV Placebo (Matching 25 mg ODV) Participants will receive ODV placebo (matching 25 [mg] ODV [125 mg tablet]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1. Drug: SMV Placebo (Matching 150 mg SMV)* Participants will receive SMV Placebo (matching 150 mg SMV [275 mg capsules]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C. Drug: AL-335 Placebo (matching 1200 mg AL-335)* Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 [3400 mg tablets]) administered orally on Day 15 in Treatment A and B. Drug: Moxifloxacin Placebo (matching 400 mg moxifloxacin)* Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin [1*400 mg capsule]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C.
Experimental: Panel 1: Treatment C Participants will receive odalasvir (ODV) placebo (matching 25 milligram [mg] ODV [125 mg tablet]) and simeprevir (SMV) placebo (matching 150 mg SMV [275 mg capsules]) once daily on Day 1 and moxifloxacin placebo (matching 400 mg moxifloxacin [1400 mg capsule]) as a single dose on Day 1, 2, 15 and 16 along with ODV 25 mg (125 mg tablet) and SMV 150 mg (275 mg capsule) once daily on Day 2 to 16 and AL-335 1200 mg (3400 mg tablet) single dose on Day 15 orally under fed conditions.	Drug: ODV Placebo (Matching 25 mg ODV) Participants will receive ODV placebo (matching 25 [mg] ODV [125 mg tablet]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1. Drug: SMV Placebo (Matching 150 mg SMV)* Participants will receive SMV Placebo (matching 150 mg SMV [275 mg capsules]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C. Drug: Moxifloxacin Placebo (matching 400 mg moxifloxacin)* Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin [1400 mg capsule]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C. Drug: ODV 25 mg* Participants will receive ODV 25 mg orally once daily administered on Days 2 to 16 in Treatment C. Drug: SMV 150 mg Participants will receive SMV 150 mg (275 mg capsules) orally once daily administered on Days 2 to 16 in Treatment C. Drug: AL-335 1200 mg* Participants will receive a single oral dose of AL-335 1200 mg (3*400 mg tablets) administered on Day 15 in Treatment C.
Placebo Comparator: Panel 2: Treatment E Participants will receive ODV placebo (matching 200 mg ODV [450 mg tablets]) on Days 1 and 2; ODV placebo (matching 125 mg ODV [250 mg tablets + 125 mg tablets]) on Days 3 to 7; and ODV placebo (matching 100 mg ODV [250 mg tablets] on Days 8 to 14, orally once daily under fed conditions.	Drug: ODV Placebo (Matching 200 mg ODV) Participants will receive ODV placebo (matching 200 mg ODV [450 mg tablets]) on Days 1 and 2 in Treatment E. Drug: ODV Placebo (Matching 125 mg ODV)* Participants will receive ODV placebo (matching 125 mg ODV [250 mg tablets + 125 mg tablets]) orally once daily on Days 3 to 7 in Treatment E. Drug: ODV Placebo (Matching 100 mg ODV) Participants will receive ODV placebo (matching 100 mg ODV [2*50 mg tablets] orally once daily on Days 8 to 14 in Treatment E.
Experimental: Panel 2: Treatment F Participants will receive ODV 200 mg (450 mg tablets) on Days 1 and 2; ODV 125 mg (250 mg tablets + 125 mg tablets) on Days 3 to 7, and ODV 100 mg (250 mg tablets) on Days 8 to 14, orally once daily under fed conditions.	Drug: ODV 200 mg Participants will receive ODV 200 mg (450 mg tablets) orally once daily will be administered on Days 1 and 2 in Treatment F. Drug: ODV 125 mg* Participants will receive ODV 125 mg (250 mg tablets + 125 mg tablets) once daily administered on Days 3 to 7 in Treatment F. Drug: ODV 100 mg Participants will receive ODV 100 mg (2*50 mg tablets) orally once daily administered on Days 8 to 14 in Treatment F.