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

NCT ID: NCT02231671

Last Updated: 2017-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-11-30

Brief Summary

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

Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ALS-008176

Intervention Type DRUG

ALS-008112

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

ALS-008176

Intervention Type DRUG

Interventions

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ALS-008176

Intervention Type DRUG

ALS-008112

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alios Biopharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pui Leung

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical

Locations

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Quotient Clinical

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ALS-008176-504

Identifier Type: -

Identifier Source: org_study_id