NCT02478333

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants

A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ALS-008176 following oral administration of single ascending dose of ALS-008176 in healthy Japanese adult participants.

Detailed description

This is a double-blind (test or experiment in which neither the person giving the treatment nor the patient knows which treatment the patient is receiving), placebo-controlled, randomized (study medication assigned to participants by chance) and single-center study of ALS-008176. The duration of study will be approximately 6 weeks for each participant. The study consists of 3 parts: Screening Phase (28 days before study commences on Day 1); double-blind Treatment Phase (single oral dose of ALS-008176 or placebo on Day 1 under fasted condition); and Follow up Phase (up to 14 days after study drug administration). All the eligible participants will be randomly assigned to receive either a single oral dose of ALS-008176 or placebo in each group. The planned doses will be escalated in a stepwise fashion if the safety and tolerability in the preceding dose is found acceptable. Participants in Group 1 will receive ALS-008176, 250 milligram (mg) or placebo, Group 2 will receive ALS-008176, 500 mg or placebo and Group 3 will receive ALS-008176, 750 mg or placebo. Study drug will be administered following a 10-hour overnight fast. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Pharmacokinetics of ALS-008176, ALS-008206, ALS-008112, and its metabolite ALS 008144 will be evaluated primarily. Participants' safety will be monitored throughout the study.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	ALS-008176 (250 mg)	Participants will receive ALS-008176, 250 mg oral suspension once on Day 1 under fasted conditions.
DRUG	ALS-008176 (500 mg)	Participants will receive ALS-008176, 500 mg oral suspension once on Day 1 under fasted conditions.
DRUG	ALS-008176 (750 mg)	Participants will receive ALS-008176, 750 mg oral suspension once on Day 1 under fasted conditions.
OTHER	Placebo	Participants will receive placebo oral suspension once on Day 1 under fasted conditions.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-06-23
• Last updated: 2016-07-11

Locations

1 site across 1 country: Japan