NCT03185195

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

1 month

First QC Date

March 8, 2017

Last Update Submit

June 9, 2017

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (22)

  • Absolute bioavailability (F) of AQX-1125

    0 - 96 hrs

  • Mass balance recovery of total radioactivity in urine, faeces and all excreta

    Measure amount excreted (Ae)

    0 -168 hrs

  • Mass balance recovery of total radioactivity in urine, faeces and all excreta

    Measure Ae as a percentage of the administered dose (%Ae)

    0 -168 hrs

  • Mass balance recovery of total radioactivity in urine, faeces and all excreta

    Cumulative recovery of Ae (Cum Ae)

    0 -168 hrs

  • Mass balance recovery of total radioactivity in urine, faeces and all excreta

    Cum Ae expressed as a percentage of the administered dose (Cum %Ae)

    0 -168 hrs

  • Metabolite profiling and structural identification in plasma, urine and faeces to estimate the routes and rates of elimination of [14-C]-AQX-1125

    0 -168 hrs

  • Measure Ae total radioactivity for urine and faeces

    0-168 hrs

  • Measure %Ae total radioactivity for urine and faeces

    0-168 hrs

  • Measure Cum Ae (total) for urine and faeces

    0-168 hrs

  • Measure Cum% Ae (total) for urine and faeces

    0-168 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration

    Cmax

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    Tmax

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    Tlag

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    AUC (0-24)

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    AUC (0-last)

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    AUC (0-inf)

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    AUC % extrap

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    lambda-z

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    T1/2

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    CL/F

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    Vz/F

    0 -96 hrs

  • Measure PK parameters of total radioactivity in plasma following oral administration:

    MRT

    0 -96 hrs

Secondary Outcomes (42)

  • PK parameters of AQX-1125 in plasma following oral administration (Part 1)

    0-96 hrs

  • PK parameters of AQX-1125 in plasma following oral administration (Part 1)

    0-96 hrs

  • PK parameters of AQX-1125 in plasma following oral administration (Part 1)

    0-96 hrs

  • PK parameters of AQX-1125 in plasma following oral administration (Part 1)

    0-96 hrs

  • PK parameters of AQX-1125 in plasma following oral administration (Part 1)

    0-96 hrs

  • +37 more secondary outcomes

Study Arms (3)

AQX-1125 Oral Tablet

EXPERIMENTAL

AQX-1125 - Oral Tablet

Drug: AQX-1125 Oral Tablet

[14C]-AQX-1125 IV

EXPERIMENTAL

Radiolabelled AQX-1125 - Intravenous

Drug: [14C]-AQX-1125 IV

[14C]-AQX-1125 Oral Solution

EXPERIMENTAL

Radiolabelled AQX-1125 - Oral Solution

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

Interventions

AQX-1125 Oral TabletDRUG

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.

AQX-1125 Oral Tablet
[14C]-AQX-1125 IVDRUG

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.

Also known as: Radiolabelled AQX-1125 IV
[14C]-AQX-1125 IV
[14C]-AQX-1125 Oral SolutionDRUG

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.

Also known as: Radiolabelled AQX-1125 Oral Solution
[14C]-AQX-1125 Oral Solution

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol

Study Officials

  • Dr.Nand Singh, MD

    Quotient Clinical

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open-Label
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

June 14, 2017

Study Start

November 22, 2016

Primary Completion

January 4, 2017

Study Completion

January 4, 2017

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)