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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing, Multiple Ascending Dosing and Food-effect in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906164
• Other study ID #: ALS-8176-501
• Secondary ID: 2012-004894-14
• Status: Completed
• Phase: Phase 1
• First received: July 3, 2013
• Last updated: October 27, 2017
• Start date: May 31, 2013
• Est. completion date: November 30, 2013

Study information

• Verified date: October 2017
• Source: Alios Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 30, 2013
• Est. primary completion date: November 30, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• ALS-008176

• Placebo

Locations

Country	Name	City	State
France	Investigational Site	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Alios Biopharma Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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