A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176

A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of 14C-ALS-008176 in Healthy Male Subjects

The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from the body.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Drug: ALS-008176; Drug: ALS-008112

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Body mass index 18.0 to 32.0 kg/m2 (inclusive) and a total body weight >50 kg

Exclusion Criteria:

• Creatinine clearance as calculated by the Cockroft-Gault formula of less than 60 mL/min
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator or the sponsor medical monitor. Reticulocyte count, haemoglobin and platelet counts must not be less than the lower limit of normal for the subject.
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, GI, haematological, neurological, endocrinological, immunological, musculoskeletal disease or any uncontrolled medical illness (eg active infection) or psychiatric disorder, as judged by the investigator or medical monitor.
• Clinically significant abnormal electrocardiogram (ECG) findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Absolute Bioavilability; Part 1 of this study is an absolute bioavailability study where the IV (intravenous) microtracer dose of ALS-008112 is administered 15-30 minutes after the oral dose to determine the bioavailability of the oral dose compared to the IV dose. The maximum microtracer IV dose administered in Part 1 of this study will not exceed a single dose of 100 μg [14C]-ALS-008112 containing NMT (not more than) 37.0 kBq (1000 nCi) 14C. Based upon previous clinical observations, it is anticipated that the single oral dose and IV microdose to be utilised in Part 1 will provide acceptable PK data and will be safe and well tolerated.	Drug: ALS-008176; Drug: ALS-008112
Experimental: Part 2: Mass Balance; Part 2 of this study is an absorption, metabolism and excretion study, for which a single 375 mg [14C]-ALS-008176 (containing NMT 6.85 MBq (megabecquerel) (185 μCi) 14C) dose has been selected for evaluation based upon data from prior studies. Based upon previous clinical observations, it is anticipated that the dose to be utilised in Part 2 will provide acceptable PK data, will be safe and well tolerated and is within the therapeutic range.	Drug: ALS-008176

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Bioavailability	Determination of the absolute bioavailability of ALS-008112	Days 1-8
Mass Balance	Mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined: amount excreted (Ae) and Ae as a percentage of the administered dose (%Ae)	Days 1 - 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Safety will be evaluated by recording adverse events, clinical laboratory results, vital signs, 12-lead ECGs, physical exams, etc.	Days 1-14
To investigate the metabolic profile of [14C] - ALS-008176	To investigate the metabolic profile of [14C] - ALS-008176 in plasma, urine and faeces following oral administration in healthy male subjects (Part 2 only)	Days 1-14

Collaborators and Investigators

• Sponsor: Alios Biopharma Inc.
• Investigators: Principal Investigator: Pui Leung, Quotient Clinical

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2014
• Primary Completion (Actual): September 30, 2014
• Study Completion (Actual): November 30, 2014

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: September 3, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: ALS-008176-504

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No