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

Alios Biopharma

Status and phase: Completed; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: ALS-008112; Drug: ALS-008176

Study type: Interventional

Funder types: Industry

Identifiers

NCT02231671

ALS-008176-504

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Part 1: Absolute Bioavilability

Experimental group

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.

Treatment:

Drug: ALS-008176

Drug: ALS-008112

Part 2: Mass Balance

Experimental group

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.

Treatment:

Drug: ALS-008176