Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125

NCT ID: NCT03185195

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-22
• Study Completion Date: 2017-01-04

Brief Summary

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

Detailed 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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

AQX-1125 Oral Tablet

AQX-1125 - Oral Tablet

Group Type: EXPERIMENTAL

AQX-1125 Oral Tablet

Intervention Type: DRUG

Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.

[14C]-AQX-1125 IV

Radiolabelled AQX-1125 - Intravenous

Group Type: EXPERIMENTAL

[14C]-AQX-1125 IV

Intervention Type: DRUG

Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.

[14C]-AQX-1125 Oral Solution

Radiolabelled AQX-1125 - Oral Solution

Group Type: EXPERIMENTAL

[14C]-AQX-1125 Oral Solution

Intervention Type: DRUG

Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.

Interventions

AQX-1125 Oral Tablet

Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.

Intervention Type: DRUG

[14C]-AQX-1125 IV

Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.

Intervention Type: DRUG

[14C]-AQX-1125 Oral Solution

Part 1: Subjects will receive a single oral dose of AQX-1125 followed by \[14C\]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive \[14C\]-AQX-1125 oral solution.

Intervention Type: DRUG

Other Intervention Names

Radiolabelled AQX-1125 IV; Radiolabelled AQX-1125 Oral Solution

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Quotient Clinical

OTHER

Sponsor Role: collaborator

Aquinox Pharmaceuticals (Canada) Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr.Nand Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Quotient Clinical

Locations

Quotient Clinical

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

AQX-1125-103

Identifier Type: -

Identifier Source: org_study_id