Back to resultsA Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
ALS-008176
ALS-008112
Sponsored by
About this trial
This is an interventional basic science trial for Respiratory Syncytial Virus Infections
Eligibility 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
Sites / Locations
- Quotient Clinical
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1: Absolute Bioavilability
Part 2: Mass Balance
Arm Description
Part 1 of this study is an absolute bioavailability study where the IV (intravenous) microtracer dose of ALS-008112 is administered 15-30 minutes after the oral dose to determine the bioavailability of the oral dose compared to the IV dose. The maximum microtracer IV dose administered in Part 1 of this study will not exceed a single dose of 100 μg [14C]-ALS-008112 containing NMT (not more than) 37.0 kBq (1000 nCi) 14C. Based upon previous clinical observations, it is anticipated that the single oral dose and IV microdose to be utilised in Part 1 will provide acceptable PK data and will be safe and well tolerated.
Part 2 of this study is an absorption, metabolism and excretion study, for which a single 375 mg [14C]-ALS-008176 (containing NMT 6.85 MBq (megabecquerel) (185 μCi) 14C) dose has been selected for evaluation based upon data from prior studies. Based upon previous clinical observations, it is anticipated that the dose to be utilised in Part 2 will provide acceptable PK data, will be safe and well tolerated and is within the therapeutic range.
Outcomes
Primary Outcome Measures
Absolute Bioavailability
Determination of the absolute bioavailability of ALS-008112
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)
Secondary Outcome Measures
Safety
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
To investigate the metabolic profile of [14C] - ALS-008176 in plasma, urine and faeces following oral administration in healthy male subjects (Part 2 only)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02231671
Brief Title
A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176
Official Title
A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of 14C-ALS-008176 in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 31, 2014 (Actual)
Primary Completion Date
September 30, 2014 (Actual)
Study Completion Date
November 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alios Biopharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see how ALS-008176 is taken up, broken down, and removed from the body.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: Absolute Bioavilability
Arm Type
Experimental
Arm Description
Part 1 of this study is an absolute bioavailability study where the IV (intravenous) microtracer dose of ALS-008112 is administered 15-30 minutes after the oral dose to determine the bioavailability of the oral dose compared to the IV dose. The maximum microtracer IV dose administered in Part 1 of this study will not exceed a single dose of 100 μg [14C]-ALS-008112 containing NMT (not more than) 37.0 kBq (1000 nCi) 14C. Based upon previous clinical observations, it is anticipated that the single oral dose and IV microdose to be utilised in Part 1 will provide acceptable PK data and will be safe and well tolerated.
Arm Title
Part 2: Mass Balance
Arm Type
Experimental
Arm Description
Part 2 of this study is an absorption, metabolism and excretion study, for which a single 375 mg [14C]-ALS-008176 (containing NMT 6.85 MBq (megabecquerel) (185 μCi) 14C) dose has been selected for evaluation based upon data from prior studies. Based upon previous clinical observations, it is anticipated that the dose to be utilised in Part 2 will provide acceptable PK data, will be safe and well tolerated and is within the therapeutic range.
Intervention Type
Drug
Intervention Name(s)
ALS-008176
Intervention Type
Drug
Intervention Name(s)
ALS-008112
Primary Outcome Measure Information:
Title
Absolute Bioavailability
Description
Determination of the absolute bioavailability of ALS-008112
Time Frame
Days 1-8
Title
Mass Balance
Description
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)
Time Frame
Days 1 - 14
Secondary Outcome Measure Information:
Title
Safety
Description
Safety will be evaluated by recording adverse events, clinical laboratory results, vital signs, 12-lead ECGs, physical exams, etc.
Time Frame
Days 1-14
Title
To investigate the metabolic profile of [14C] - ALS-008176
Description
To investigate the metabolic profile of [14C] - ALS-008176 in plasma, urine and faeces following oral administration in healthy male subjects (Part 2 only)
Time Frame
Days 1-14
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pui Leung
Organizational Affiliation
Quotient Clinical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Clinical
City
Nottingham
ZIP/Postal Code
NG11 6JS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and Absolute Bioavailability of ALS-008176
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