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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

May 12, 2017

Primary Completion Date

October 27, 2017

Study Completion Date

October 27, 2017

Conditions

Healthy

Interventions

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.

Trial Locations (1)

85283

Celerion, Tempe

All Listed Sponsors

lead

Janssen Research & Development, LLC

INDUSTRY