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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01906164
• Date of registration: 03/07/2013
• Prospective Registration: No
• Primary sponsor: Alios Biopharma Inc.
• Public title: Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
• Scientific 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
• Date of first enrolment: May 31, 2013
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01906164
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Matthew McClure, M.D.
• Affiliation: Alios BioPharma

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Syncytial Virus Infections

Intervention(s)

Drug: ALS-008176

Drug: Placebo

Primary Outcome(s)

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(s)

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]

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]

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 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]

Secondary ID(s)

ALS-8176-501

2012-004894-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors