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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

NCT ID: NCT03155893

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-12

Study Completion Date

2017-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Panel 1: Treatment A

Participants will receive odalasvir (ODV) placebo (matching 25 milligram \[mg\] ODV \[1\*25 mg tablet\]) and simeprevir (SMV) placebo (matching 150 mg SMV \[2\*75 mg capsules\]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram \[mg\] AL-335 \[3\*400 mg tablets\]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin \[1\*400 mg capsule\]) 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.

Group Type EXPERIMENTAL

ODV Placebo (Matching 25 mg ODV)

Intervention Type DRUG

Participants will receive ODV placebo (matching 25 \[mg\] ODV \[1\*25 mg tablet\]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1.

SMV Placebo (Matching 150 mg SMV)

Intervention Type DRUG

Participants will receive SMV Placebo (matching 150 mg SMV \[2\*75 mg capsules\]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C.

AL-335 Placebo (matching 1200 mg AL-335)

Intervention Type DRUG

Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 \[3\*400 mg tablets\]) administered orally on Day 15 in Treatment A and B.

Moxifloxacin Placebo (matching 400 mg moxifloxacin)

Intervention Type DRUG

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.

Panel 1: Treatment B

Participants will receive odalasvir (ODV) placebo (matching 25 milligram \[mg\] ODV \[1\*25 mg tablet\]) and simeprevir (SMV) placebo (matching 150 mg SMV \[2\*75 mg capsules\]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram \[mg\] AL-335 \[3\*400 mg tablets\]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin \[1\*400 mg capsule\]) 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.

Group Type EXPERIMENTAL

ODV Placebo (Matching 25 mg ODV)

Intervention Type DRUG

Participants will receive ODV placebo (matching 25 \[mg\] ODV \[1\*25 mg tablet\]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1.

SMV Placebo (Matching 150 mg SMV)

Intervention Type DRUG

Participants will receive SMV Placebo (matching 150 mg SMV \[2\*75 mg capsules\]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C.

AL-335 Placebo (matching 1200 mg AL-335)

Intervention Type DRUG

Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 \[3\*400 mg tablets\]) administered orally on Day 15 in Treatment A and B.

Moxifloxacin Placebo (matching 400 mg moxifloxacin)

Intervention Type DRUG

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.

Panel 1: Treatment C

Participants will receive odalasvir (ODV) placebo (matching 25 milligram \[mg\] ODV \[1\*25 mg tablet\]) and simeprevir (SMV) placebo (matching 150 mg SMV \[2\*75 mg capsules\]) once daily on Day 1 and moxifloxacin placebo (matching 400 mg moxifloxacin \[1\*400 mg capsule\]) as a single dose on Day 1, 2, 15 and 16 along with ODV 25 mg (1\*25 mg tablet) and SMV 150 mg (2\*75 mg capsule) once daily on Day 2 to 16 and AL-335 1200 mg (3\*400 mg tablet) single dose on Day 15 orally under fed conditions.

Group Type EXPERIMENTAL

ODV Placebo (Matching 25 mg ODV)

Intervention Type DRUG

Participants will receive ODV placebo (matching 25 \[mg\] ODV \[1\*25 mg tablet\]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1.

SMV Placebo (Matching 150 mg SMV)

Intervention Type DRUG

Participants will receive SMV Placebo (matching 150 mg SMV \[2\*75 mg capsules\]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C.

Moxifloxacin Placebo (matching 400 mg moxifloxacin)

Intervention Type DRUG

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.

ODV 25 mg

Intervention Type DRUG

Participants will receive ODV 25 mg orally once daily administered on Days 2 to 16 in Treatment C.

SMV 150 mg

Intervention Type DRUG

Participants will receive SMV 150 mg (2\*75 mg capsules) orally once daily administered on Days 2 to 16 in Treatment C.

AL-335 1200 mg

Intervention Type DRUG

Participants will receive a single oral dose of AL-335 1200 mg (3\*400 mg tablets) administered on Day 15 in Treatment C.

Panel 2: Treatment E

Participants will receive ODV placebo (matching 200 mg ODV \[4\*50 mg tablets\]) on Days 1 and 2; ODV placebo (matching 125 mg ODV \[2\*50 mg tablets + 1\*25 mg tablets\]) on Days 3 to 7; and ODV placebo (matching 100 mg ODV \[2\*50 mg tablets\] on Days 8 to 14, orally once daily under fed conditions.

Group Type PLACEBO_COMPARATOR

ODV Placebo (Matching 200 mg ODV)

Intervention Type DRUG

Participants will receive ODV placebo (matching 200 mg ODV \[4\*50 mg tablets\]) on Days 1 and 2 in Treatment E.

ODV Placebo (Matching 125 mg ODV)

Intervention Type DRUG

Participants will receive ODV placebo (matching 125 mg ODV \[2\*50 mg tablets + 1\*25 mg tablets\]) orally once daily on Days 3 to 7 in Treatment E.

ODV Placebo (Matching 100 mg ODV)

Intervention Type DRUG

Participants will receive ODV placebo (matching 100 mg ODV \[2\*50 mg tablets\] orally once daily on Days 8 to 14 in Treatment E.

Panel 2: Treatment F

Participants will receive ODV 200 mg (4\*50 mg tablets) on Days 1 and 2; ODV 125 mg (2\*50 mg tablets + 1\*25 mg tablets) on Days 3 to 7, and ODV 100 mg (2\*50 mg tablets) on Days 8 to 14, orally once daily under fed conditions.

Group Type EXPERIMENTAL

ODV 200 mg

Intervention Type DRUG

Participants will receive ODV 200 mg (4\*50 mg tablets) orally once daily will be administered on Days 1 and 2 in Treatment F.

ODV 125 mg

Intervention Type DRUG

Participants will receive ODV 125 mg (2\*50 mg tablets + 1\*25 mg tablets) once daily administered on Days 3 to 7 in Treatment F.

ODV 100 mg

Intervention Type DRUG

Participants will receive ODV 100 mg (2\*50 mg tablets) orally once daily administered on Days 8 to 14 in Treatment F.

Interventions

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ODV Placebo (Matching 25 mg ODV)

Participants will receive ODV placebo (matching 25 \[mg\] ODV \[1\*25 mg tablet\]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1.

Intervention Type DRUG

ODV Placebo (Matching 200 mg ODV)

Participants will receive ODV placebo (matching 200 mg ODV \[4\*50 mg tablets\]) on Days 1 and 2 in Treatment E.

Intervention Type DRUG

ODV Placebo (Matching 125 mg ODV)

Participants will receive ODV placebo (matching 125 mg ODV \[2\*50 mg tablets + 1\*25 mg tablets\]) orally once daily on Days 3 to 7 in Treatment E.

Intervention Type 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.

Intervention Type DRUG

SMV Placebo (Matching 150 mg SMV)

Participants will receive SMV Placebo (matching 150 mg SMV \[2\*75 mg capsules\]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C.

Intervention Type DRUG

AL-335 Placebo (matching 1200 mg AL-335)

Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 \[3\*400 mg tablets\]) administered orally on Day 15 in Treatment A and B.

Intervention Type 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.

Intervention Type DRUG

ODV 25 mg

Participants will receive ODV 25 mg orally once daily administered on Days 2 to 16 in Treatment C.

Intervention Type DRUG

ODV 200 mg

Participants will receive ODV 200 mg (4\*50 mg tablets) orally once daily will be administered on Days 1 and 2 in Treatment F.

Intervention Type DRUG

ODV 125 mg

Participants will receive ODV 125 mg (2\*50 mg tablets + 1\*25 mg tablets) once daily administered on Days 3 to 7 in Treatment F.

Intervention Type 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.

Intervention Type DRUG

SMV 150 mg

Participants will receive SMV 150 mg (2\*75 mg capsules) orally once daily administered on Days 2 to 16 in Treatment C.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Celerion

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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64294178HPC1012

Identifier Type: OTHER

Identifier Source: secondary_id

CR108332

Identifier Type: -

Identifier Source: org_study_id