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

Phase 1CompletedNCT01906164

Alios Biopharma Inc.101 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

101

Conditions

Respiratory Syncytial Virus Infections

Interventions

ALS-008176DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Investigational Site

Rennes, France

Outcomes

Primary Outcomes

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)

Time frame: 11 days

Secondary Outcomes

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

Time frame: 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

Time frame: 11 days

Urinary excretion and concentrations of ALS-008176 and metabolites after a single oral dose and multiple doses in healthy volunteers in fasted conditions

Time frame: 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

Time frame: 11 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.