Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers

Phase 1

Completed

• Conditions: Respiratory Syncytial Virus Infections
• Interventions: Drug: ALS-008176; Drug: Placebo

• Registration Number: NCT01906164
• Lead Sponsor: Alios Biopharma Inc.

Brief Summary

This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-31
• Study First Submitted: 2013-07-03
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-24
• Primary Completion: 2013-11-30
• Study Completion: 2013-11-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Male or female subjects, 18-55 years of age, in good health with screening laboratory values within limits specified by the protocol
• Body mass index 18-30 kg/m2
• Female subjects must be of non-childbearing potential; male subjects must be surgically sterile or practicing birth control

Exclusion Criteria

• Clinically significant or uncontrolled medical illness
• Use, or anticipated use during conduct of the study, of concomitant medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALS-008176	ALS-008176	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety data including, but not limited to, tabulation of adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results (including chemistry, hematology, and urine)	11 days

Secondary Outcome Measures

Name	Time	Method
Urinary excretion and concentrations of ALS-008176 and metabolites after a single oral dose and multiple doses in healthy volunteers in fasted conditions	11 days
PK parameters of ALS-008176 and metabolites in plasma following single dose administration: Cmax, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h, AUC0-inf or AUC0-last	11 days
PK parameters of ALS-008176 and metabolites in plasma after a single oral dose in healthy volunteers in fasted conditions as compared with fed conditions: Cmax, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h, AUC0-inf or AUC0-last	11 days
PK parameters of ALS-008176 and metabolites in plasma following repeat dose administration: Cmax, Cmin, tmax, t1/2, CL/F and Vdss/F (not for metabolites), AUC0-24h , AUC0-last and AUC0 tau	11 days

Trial Locations

Locations (1)

Investigational Site; 🇫🇷 Rennes, France