Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125 (ADME)

Aquinox Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: [14C]-AQX-1125 Oral Solution; Drug: [14C]-AQX-1125 IV; Drug: AQX-1125 Oral Tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03185195

AQX-1125-103

Details and patient eligibility

About

This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects.

Full description

This is a single-centre, open-label, non-randomised, 2-part, sequential dose study in healthy male and female subjects. It is planned to enrol a single cohort of 8 healthy subjects (4 male and 4 female) who will participate in Part 1 and Part 2 of the study.

In Part 1, each subject will receive a single oral dose of AQX-1125 followed by an IV microtracer dose of carbon-14-AQX-1125 ([14C]-AQX-1125). In Part 2, each subject will receive a single oral dose of [14C]-AQX-1125.

Enrollment: 9 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males
• Healthy females of non-child bearing potential
• BMI 18.0 to 35 kg/m2

Exclusion criteria

• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
• Current smokers and those who had smoked within the last 12 months; this included cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test result at screening and each admission
• Clinically significant abnormal clinical chemistry, haematology, urinalysis or electrocardiogram (ECG)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

AQX-1125 Oral Tablet

Experimental group

Description:

AQX-1125 - Oral Tablet

Treatment:

Drug: AQX-1125 Oral Tablet

[14C]-AQX-1125 IV

Experimental group

Description:

Radiolabelled AQX-1125 - Intravenous

Treatment:

Drug: [14C]-AQX-1125 IV

[14C]-AQX-1125 Oral Solution

Experimental group

Description:

Radiolabelled AQX-1125 - Oral Solution

Treatment:

Drug: [14C]-AQX-1125 Oral Solution