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

• Status: Completed
• Trial end date: 2014-11-30
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alios Biopharma Inc.

Criteria

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