NCT03155893

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2017-05-12
• Primary completion: 2017-10-27
• Completion: 2017-10-27
• First posted: 2017-05-16
• Last updated: 2017-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study