Not provided
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 Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabeled with a small amount of carbon-14 so it can be tracked in the body.
This study will take place at one site in Nottingham, United Kingdom, and will enroll 2 groups of 8 healthy men aged 30-65 years.
This study in healthy volunteers aims to explore blood levels and side effects of the test medicine, and look at how it is broken down when injected into a vein or given as a liquid by mouth. The test medicine will be radiolabelled with a small amount of carbon-14 so it can be tracked in the body.
This study will take place at one site in Nottingham, United Kingdom.
It is planned to enroll 2 groups of 8 healthy men aged 30-65 years.
Each group will take part in 1 treatment period and receive a single dose of radiolabelled test medicine, either by injection into a vein or as a liquid by mouth. They'll stay in the clinic for up to 10 nights, attend 2 outpatient visits, and take up to 7 weeks to finish the study.
Blood and urine samples will be collected to do safety tests. Blood, urine and faecal samples will be collected to measure the amount of test medicine and its breakdown products.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | Participants in Cohort 1 will receive a single intravenous injection of [14C]AZD4144 Solution for Infusion |
|
| Regimen B | Experimental | Participants in Cohort 2 will receive a single oral dose of [14C]AZD4144 Oral Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]AZD4144 Solution for Infusion | Drug | Intravenous, fasted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of AZD4144 excreted (Ae) | Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta | Urine and faecal samples collected from pre-dose until up to 216 hours post-dose |
| Amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (Fe) | Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faeces and all excreta | Urine and faecal samples collected from pre-dose until up to 216 hours post-dose |
| Cumulative amount of AZD4144 excreted (CumAe) | Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta | Urine and faecal samples collected from pre-dose until up to 216 hours post-dose |
| Cumulative amount of AZD4144 excreted expressed as a percentage of the radioactive dose administered (CumFe) | Mass balance recovery, rates and routes of elimination of total radioactivity of [14C]AZD4144 in urine, faecal and all excreta | Urine and faecal samples collected from pre-dose until up to 216 hours post-dose |
| Area under the curve (AUC) of circulating plasma total radioactivity (TR) accounting for 10% or more of the dose | Identification of the chemical structure of each metabolite accounting for more than 10% by AUC of circulating total radioactivity | Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose |
| 80% or more of the radioactivity recovered in excreta |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum observed concentration (tmax) for AZD4144 and total radioactivity | The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood | Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Maximum observed concentration (Cmax) for AZD4144 and total radioactivity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sharan Sidhu, MBChB, BAO | Quotient Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ruddington | NG11 6JS | United Kingdom |
Qualified researchers can request access to anonymized individual participant-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Not provided
Cohorts 1 and 2 are each single arm regimens
Not provided
Not provided
Not provided
Not provided
| [14C]AZD4144 Oral Solution | Drug | Oral, fasted |
|
|
Identification of greater than 80% of the radioactivity recovered in the urine and/or faeces
| Plasma, urine and faecal samples from pre-dose until up to 216 hours post-dose |
The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood |
| Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) for AZD4144 and total radioactivity | The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood | Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4144 and total radioactivity | The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood | Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) for AZD4144 and total radioactivity | The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood | Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Terminal elimination half-life (T1/2) for AZD4144 and total radioactivity | The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood | Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Apparent volume of distribution at steady state after a single IV administration (Vss) for AZD4144 and total radioactivity | The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood | Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Total body clearance calculated after a single IV administration (CL) for AZD4144 and total radioactivity | The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood | Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Renal clearance calculated using plasma AUC (CLR) for AZD4144 and total radioactivity | The PK of AZD4144 in plasma and urine, and total radioactivity in plasma and whole blood | Plasma, urine and whole blood samples collected from pre-dose until up to 168 hours post-dose |
| Whole blood:plasma concentration ratios | Whole blood:plasma concentration ratios for total radioactivity | Whole blood and plasma samples collected from pre-dose until 168 hours post-dose |
| Absolute bioavailability | Absolute bioavailability (F) of AZD4144 based on AUC0-inf | Plasma samples collected from pre-dose until 168 hours post-dose |