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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alios Biopharma Inc.
ClinicalTrials.gov Identifier:
NCT01906164
First received: July 3, 2013
Last updated: May 13, 2014
Last verified: May 2014
  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 ]

Enrollment: 101
Study Start Date: May 2013
Study Completion Date: November 2013
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906164

Locations
France
Investigational Site
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: May 13, 2014
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 September 14, 2014