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

This study is currently recruiting participants.
Verified July 2013 by Alios Biopharma Inc.
Sponsor:
Information provided by (Responsible Party):
Alios Biopharma Inc.
ClinicalTrials.gov Identifier:
NCT01906164
First received: July 3, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Respiratory Syncytial Virus Infections
Drug: ALS-008176
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alios Biopharma Inc.:

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) [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 11 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: May 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALS-008176 Drug: ALS-008176
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01906164

Contacts
Contact: Abbie Oey 650-635-5530 aoey@aliosbiopharma.com

Locations
France
Investigational Site Recruiting
Rennes, France
Sponsors and Collaborators
Alios Biopharma Inc.
Investigators
Study Director: Matthew McClure, M.D. Alios BioPharma
  More Information

No publications provided

Responsible Party: Alios Biopharma Inc.
ClinicalTrials.gov Identifier: NCT01906164     History of Changes
Other Study ID Numbers: ALS-8176-501, 2012-004894-14
Study First Received: July 3, 2013
Last Updated: July 23, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Alios Biopharma Inc.:
RSV

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on April 15, 2014