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

NCT02231671 | Completed Phase 1

• 1 other identifier: ALS-008176-504
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Safety

  Days 1-14

• To investigate the metabolic profile of [14C] - ALS-008176

  Days 1-14

Study Arms (2)

Part 1: Absolute Bioavilability

EXPERIMENTAL

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

Part 2: Mass Balance

EXPERIMENTAL

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

Interventions

ALS-008176 DRUG

Part 1: Absolute Bioavilability; Part 2: Mass Balance

ALS-008112 DRUG

Part 1: Absolute Bioavilability

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alios Biopharma Inc.: lead

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

4'-chloromethyl-2'-deoxy-3',5'-di-O-isobutyryl-2'-fluorocytidine

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Pui Leung

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 4, 2014
• Study Start: August 31, 2014
• Primary Completion: September 30, 2014
• Study Completion: November 30, 2014
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

GB (1)