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

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ClinicalTrials.gov Identifier: NCT01906164
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Alios Biopharma Inc.

July 3, 2013
July 24, 2013
October 31, 2017
May 31, 2013
November 30, 2013   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01906164 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Respiratory Syncytial Virus Infections
  • Drug: ALS-008176
  • Drug: Placebo
  • Experimental: ALS-008176
    Intervention: Drug: ALS-008176
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
101
144
November 30, 2013
November 30, 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01906164
ALS-8176-501
2012-004894-14 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Alios Biopharma Inc.
Alios Biopharma Inc.
Not Provided
Study Director: Matthew McClure, M.D. Alios BioPharma
Alios Biopharma Inc.
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP