Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
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
2 other identifiers
interventional
101
1 country
1
Brief Summary
This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2013
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2013
CompletedFirst Submitted
Initial submission to the registry
July 3, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2013
CompletedOctober 31, 2017
October 1, 2017
6 months
July 3, 2013
October 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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 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
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 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
Study Arms (2)
ALS-008176
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Clinically significant or uncontrolled medical illness
- Use, or anticipated use during conduct of the study, of concomitant medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Investigational Site
Rennes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Matthew McClure, M.D.
Alios BioPharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2013
First Posted
July 24, 2013
Study Start
May 31, 2013
Primary Completion
November 30, 2013
Study Completion
November 30, 2013
Last Updated
October 31, 2017
Record last verified: 2017-10