Status:
COMPLETED
A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176
Lead Sponsor:
Alios Biopharma Inc.
Conditions:
Respiratory Syncytial Virus Infections
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from the body.
Eligibility Criteria
Inclusion
- Body mass index 18.0 to 32.0 kg/m2 (inclusive) and a total body weight \>50 kg
Exclusion
- 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
Key Trial Info
Start Date :
August 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02231671
Start Date
August 31 2014
End Date
November 30 2014
Last Update
October 31 2017
Active Locations (1)
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1
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS