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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02231671
• Other study ID #: ALS-008176-504
• Status: Completed
• Phase: Phase 1
• First received: August 29, 2014
• Last updated: October 27, 2017
• Start date: August 31, 2014
• Est. completion date: November 30, 2014

Study information

• Verified date: October 2017
• Source: Alios Biopharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 30, 2014
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• ALS-008176

• ALS-008112

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Alios Biopharma Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Bioavailability	Determination of the absolute bioavailability of ALS-008112	Days 1-8
Primary	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	Safety	Safety will be evaluated by recording adverse events, clinical laboratory results, vital signs, 12-lead ECGs, physical exams, etc.	Days 1-14
Secondary	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