Healthy VolunteerPhase 1ADMENCT03185195
Phase 1 Absorption Distribution Metabolism and Excretion of AQX-1125
A Phase 1 study testing AQX-1125 Oral Tablet, [14C]-AQX-1125 IV and [14C]-AQX-1125 Oral Solution in people with Healthy Volunteer, run by Aquinox Pharmaceuticals (Canada) Inc. at 1 site in United Kingdom.
Trial summary
This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- AQX-1125 Oral Tablet, [14C]-AQX-1125 IV and [14C]-AQX-1125 Oral Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2016to 4 Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males
- Healthy females of non-child bearing potential
- BMI 18.0 to 35 kg/m2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label,2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structure for [14C]-AQX-1125 in Healthy Subjects
This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects.
Read the 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
- Being tested
- AQX-1125 Oral Tablet, [14C]-AQX-1125 IV, [14C]-AQX-1125 Oral Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
[14C]-AQX-1125 IVDrug
Also called Radiolabelled 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.
[14C]-AQX-1125 Oral SolutionDrug
Also called Radiolabelled 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.
| Study group | Role | What they receive |
|---|---|---|
| AQX-1125 Oral Tablet | Experimental | AQX-1125 - Oral Tablet Receives: Drug: AQX-1125 Oral Tablet |
| [14C]-AQX-1125 IV | Experimental | Radiolabelled AQX-1125 - Intravenous Receives: Drug: [14C]-AQX-1125 IV |
| [14C]-AQX-1125 Oral Solution | Experimental | Radiolabelled AQX-1125 - Oral Solution Receives: Drug: [14C]-AQX-1125 Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute bioavailability (F) of AQX-1125
Measured: 0 - 96 hrs
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Measure amount excreted (Ae)
Measured: 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)
Measured: 0 -168 hrs
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Cumulative recovery of Ae (Cum Ae)
Measured: 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)
Measured: 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
Measured: 0 -168 hrs
Measure Ae total radioactivity for urine and faeces
Measured: 0-168 hrs
Measure %Ae total radioactivity for urine and faeces
Measured: 0-168 hrs
Measure Cum Ae (total) for urine and faeces
Measured: 0-168 hrs
Measure Cum% Ae (total) for urine and faeces
Measured: 0-168 hrs
Measure PK parameters of total radioactivity in plasma following oral administration
Cmax
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
Tmax
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
Tlag
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
AUC (0-24)
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
AUC (0-last)
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
AUC (0-inf)
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
AUC % extrap
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
lambda-z
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
T1/2
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
CL/F
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
Vz/F
Measured: 0 -96 hrs
Measure PK parameters of total radioactivity in plasma following oral administration:
MRT
Measured: 0 -96 hrs
Secondary outcomes (42)
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of Cmax
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of Tmax
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of Tlag
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of AUC(0-24)
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of AUC(0-last)
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of AUC(0-inf)
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of AUC%extrap
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of lambda-z
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of T1/2
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of CL/F
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of Vz/F
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Measurement of MRT
Measured: 0-96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of Cmax
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of Tmax
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of Tlag
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of AUC(0-24)
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of AUC(0-last)
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of AUC(0-inf)
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of AUC%extrap
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of lambda-z
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of T1/2
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of CL
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of Vz
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of VSS
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Measurement of MRT
Measured: 0 - 96 hrs
Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs, physical examinations, ECGs and AEs (Part 1)
Measured: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of Cmax
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of Tmax
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of Tlag
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of AUC(0-24)
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of AUC(0-last)
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of AUC(0-inf)
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of AUC%extrap
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of lambda-z
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of T1/2
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of CL/F
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of Vz/F
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of F
Measured: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Measurement of MRT
Measured: 0 -168 hrs
Measure plasma whole blood concentration ratios for total radioactivity (Part 2)
Measured: 0 -168 hrs
Chemical structure of major metabolites of [14-C]-AQX-1125
Major metabolites classified as >10% of the AUC of total radioactivity in plasma and >10% dose excreted in urine and faeces following oral administration (Part 2)
Measured: 0 -168 hrs
Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs and ECG (Part 2)
Measured: 0 -168 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start22 Nov 2016
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Responsible party
- Sponsor
- Investigators
- Dr.Nand Singh, MD, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185195
- Sponsor's protocol ID
- AQX-1125-103
- Acronym
- ADME
- Status last verified
- Jun 2017
- First submitted
- 8 Mar 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label,2-Part Sequential Dose Study Designed to Assess the Absolute Bioavailability, Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structure for [14C]-AQX-1125 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03185195
- Acronym / sponsor ID
- ADME / AQX-1125-103
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Aquinox Pharmaceuticals (Canada) Inc.Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AQX-1125 Oral Tablet | Experimental | Drug: AQX-1125 Oral TabletAQX-1125 - Oral Tablet |
| [14C]-AQX-1125 IV | Experimental | Drug: [14C]-AQX-1125 IVRadiolabelled AQX-1125 - Intravenous |
| [14C]-AQX-1125 Oral Solution | Experimental | Drug: [14C]-AQX-1125 Oral SolutionRadiolabelled AQX-1125 - Oral Solution |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males
- Healthy females of non-child bearing potential
- BMI 18.0 to 35 kg/m2
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQX-1125 Oral TabletPart 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. | Drug | AQX-1125 Oral Tablet |
| [14C]-AQX-1125 IVAlso: Radiolabelled AQX-1125 IVPart 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. | Drug | [14C]-AQX-1125 IV |
| [14C]-AQX-1125 Oral SolutionAlso: Radiolabelled AQX-1125 Oral SolutionPart 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. | Drug | [14C]-AQX-1125 Oral Solution |
Primary outcome
Absolute bioavailability (F) of AQX-1125
Time frame: 0 - 96 hrs
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Time frame: 0 -168 hrs
Measure amount excreted (Ae)
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Time frame: 0 -168 hrs
Measure Ae as a percentage of the administered dose (%Ae)
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Time frame: 0 -168 hrs
Cumulative recovery of Ae (Cum Ae)
Mass balance recovery of total radioactivity in urine, faeces and all excreta
Time frame: 0 -168 hrs
Cum Ae expressed as a percentage of the administered dose (Cum %Ae)
Metabolite profiling and structural identification in plasma, urine and faeces to estimate the routes and rates of elimination of [14-C]-AQX-1125
Time frame: 0 -168 hrs
Measure Ae total radioactivity for urine and faeces
Time frame: 0-168 hrs
Measure %Ae total radioactivity for urine and faeces
Time frame: 0-168 hrs
Measure Cum Ae (total) for urine and faeces
Time frame: 0-168 hrs
Measure Cum% Ae (total) for urine and faeces
Time frame: 0-168 hrs
Measure PK parameters of total radioactivity in plasma following oral administration
Time frame: 0 -96 hrs
Cmax
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
Tmax
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
Tlag
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
AUC (0-24)
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
AUC (0-last)
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
AUC (0-inf)
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
AUC % extrap
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
lambda-z
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
T1/2
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
CL/F
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
Vz/F
Measure PK parameters of total radioactivity in plasma following oral administration:
Time frame: 0 -96 hrs
MRT
42 secondary outcomes
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 1)
Time frame: 0-96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following IV administration (Part 1)
Time frame: 0 - 96 hrs
Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs, physical examinations, ECGs and AEs (Part 1)
Time frame: 0 - 96 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
PK parameters of AQX-1125 in plasma following oral administration (Part 2)
Time frame: 0 -168 hrs
Measure plasma whole blood concentration ratios for total radioactivity (Part 2)
Time frame: 0 -168 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Nand Singh, MD principal investigator
Quotient Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AQX-1125 Oral Tablet, [14C]-AQX-1125 IV and [14C]-AQX-1125 Oral Solution in people with Healthy Volunteer, run by Aquinox Pharmaceuticals (Canada) Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute bioavailability (F) of AQX-1125 (time frame: 0 - 96 hrs). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.