Back to resultsStudy of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
ALS-008176
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring RSV
Eligibility Criteria
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
Sites / Locations
- Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ALS-008176
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
Urinary excretion and concentrations of ALS-008176 and metabolites after a single oral dose and multiple doses in healthy volunteers in fasted conditions
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01906164
Brief Title
Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 31, 2013 (Actual)
Primary Completion Date
November 30, 2013 (Actual)
Study Completion Date
November 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alios Biopharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
RSV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ALS-008176
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ALS-008176
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew McClure, M.D.
Organizational Affiliation
Alios BioPharma
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Rennes
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
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