Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Quotient Clinical | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
This study is conducted to evaluate the absolute bioavailability, metabolism and elimination pathways of AQX-1125 in healthy male and female subjects.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AQX-1125 Oral Tablet | Experimental | AQX-1125 - Oral Tablet |
|
| [14C]-AQX-1125 IV | Experimental | Radiolabelled AQX-1125 - Intravenous |
|
| [14C]-AQX-1125 Oral Solution | Experimental | Radiolabelled AQX-1125 - Oral Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AQX-1125 Oral Tablet | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of Cmax | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of Tmax |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr.Nand Singh, MD | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Nottingham | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C582990 | 4-(4-(aminomethyl)-7a-methyl-1-methylideneoctahydro-1H-inden-5-yl)-3-(hydroxymethyl)-4-methylcyclohexan-1-ol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Open-Label
Not provided
| [14C]-AQX-1125 IV | 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 | 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. |
|
|
| 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 |
| 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of Tlag | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of AUC(0-24) | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of AUC(0-last) | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of AUC(0-inf) | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of AUC%extrap | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of lambda-z | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of T1/2 | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of CL/F | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of Vz/F | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 1) | Measurement of MRT | 0-96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of Cmax | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of Tmax | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of Tlag | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of AUC(0-24) | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of AUC(0-last) | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of AUC(0-inf) | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of AUC%extrap | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of lambda-z | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of T1/2 | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of CL | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of Vz | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of VSS | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following IV administration (Part 1) | Measurement of MRT | 0 - 96 hrs |
| Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs, physical examinations, ECGs and AEs (Part 1) | 0 - 96 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of Cmax | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of Tmax | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of Tlag | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of AUC(0-24) | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of AUC(0-last) | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of AUC(0-inf) | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of AUC%extrap | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of lambda-z | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of T1/2 | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of CL/F | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of Vz/F | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of F | 0 -168 hrs |
| PK parameters of AQX-1125 in plasma following oral administration (Part 2) | Measurement of MRT | 0 -168 hrs |
| Measure plasma whole blood concentration ratios for total radioactivity (Part 2) | 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) | 0 -168 hrs |
| Safety and tolerability assessments based on adverse events, safety laboratory tests, vital signs and ECG (Part 2) | 0 -168 hrs |