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

October 27, 2017 updated by: Alios Biopharma Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
EXPERIMENTAL: ALS-008176
Drug: ALS-008176

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
11 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alios Biopharma Inc.

Investigators

  • Study Director: Matthew McClure, M.D., Alios BioPharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 31, 2013

Primary Completion (ACTUAL)

November 30, 2013

Study Completion (ACTUAL)

November 30, 2013

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (ESTIMATE)

July 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALS-8176-501
  • 2012-004894-14 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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