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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02231671

Enrollment

Registered

2014-09-04

Start date

2014-08-31

Completion date

2014-11-30

Last updated

2017-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Brief summary

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

Interventions

DRUGALS-008176

DRUGALS-008112

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Absolute Bioavailability	Days 1-8	Determination of the absolute bioavailability of ALS-008112
Mass Balance	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

Measure	Time frame	Description
Safety	Days 1-14	Safety will be evaluated by recording adverse events, clinical laboratory results, vital signs, 12-lead ECGs, physical exams, etc.
To investigate the metabolic profile of [14C] - ALS-008176	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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026