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

NCT02478333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-07-11

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

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.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478333 on ClinicalTrials.gov