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OpenTrials
Completed

NCT Number: NCT02231671

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

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

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Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALS-008176

Drug

ALS-008112

Drug

Primary outcomes

  1. Absolute Bioavailability

    Time frame: Days 1-8

    Determination of the absolute bioavailability of ALS-008112

  2. Mass Balance

    Time frame: Days 1 - 14

    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)

Secondary outcomes

  1. Safety

    Time frame: Days 1-14

    Safety will be evaluated by recording adverse events, clinical laboratory results, vital signs, 12-lead ECGs, physical exams, etc.

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

    Time frame: Days 1-14

    To investigate the metabolic profile of [14C] - ALS-008176 in plasma, urine and faeces following oral administration in healthy male subjects (Part 2 only)

Sponsors and collaborators

Lead sponsor

Alios Biopharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 4, 2014
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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