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This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390.
On Day 1, participants will receive one dose of [14C]-AZD1390 . Participants will be confined to the study site until Day 8.
Approximately 8 enrolled male and female participants will receive study intervention in order to achieve a minimum of 4 evaluable participants.
Participants in this study will contribute to essential knowledge that will support the development of AZD1390 as a potential treatment for GBM, a malignancy of high unmet need, while being exposed to a low level of immediate risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1390 | Experimental | Single dose of [14C]-AZD1390 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1390 | Drug | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Amount excreted (Ae) (urine) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Cumulative Amount excreted (CumAe) (urine) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Amount excreted (Ae) (feaces) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Cumulative Amount excreted (CumAe) (feaces) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Amount excreted (Ae) (total - urine and feaces combined) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Cumulative Amount excreted (CumAe) (total urine and feaces combined) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Amount (percentage) excreted (Fe) (urine) | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of plasma: Maximum observed concentration (Cmax) | 6 weeks |
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Guildford | GU2 7WG | United Kingdom | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-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 shared.
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.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005909 | Glioblastoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
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| ID | Term |
|---|---|
| C000729307 | AZD1390 |
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Open label
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| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose |
Cumulative Amount (percentage) excreted (CumFe) (urine) |
| 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Amount (percentage) excreted (Fe) (feaces) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Cumulative Amount (percentage) excreted (CumAe) (feaces) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Amount (percentage) excreted (Fe) (total urine and faeces combined) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined) | 6 Weeks |
| The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose | If emesis occurs, vomitus will be analysed for total radioactivity | 6 Weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Maximum observed concentration (Cmax) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis whole blood: Maximum observed concentration (Cmax) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz ) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz ) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity | 6 weeks |
| Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose | Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity | 6 weeks |
| Pharmacokinetic(s) of AZD1390 after a single oral dose | Analysis of urine: Cumulative amount excreted (CumAe) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 after a single oral dose | Analysis of urine: Fraction (percentage) excreted (Fe) | 6 weeks |
| The distribution of total radioactivity into blood cells after a single oral dose | Analysis of urine: Fraction (percentage) excreted (Fe) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 after a single oral dose | Analysis of urine: Cumulative fraction (percentage) excreted (CumFe) | 6 weeks |
| Pharmacokinetic(s) of AZD1390 after a single oral dose | Analysis of urine: Renal clearance (CLR) | 6 weeks |
| 6 weeks |
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast) | 6 weeks |
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax) | 6 weeks |
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz ) | 6 weeks |
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) | 6 weeks |
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F) | 6 weeks |
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) | 6 weeks |
| The phamrmacokinetic(s) of AZD1390 metabolite | Analysis of metabolite in plasma: parent ratio | 6 weeks |
| Metabolic profiling following single oral dose of AZD1390 | Quantification and identification of major metabolites of AZD1390 in plasma and excreta. | 6 weeks |
| The safety of a single dose of AZD1390 | Number of participants with AEs and SAEs and severity of AEs and SAEs (based on CTCAE v5). | 6 weeks |
| The safety of a single dose of AZD1390 | Number of participants with laboratory abnormalities based on assessment of Haematology/Haemostasis (whole blood), Urinalysis (dipstick), Serology, Clinical chemistry (serum or plasma), Creatinine clearance. | 6 weeks |
| The safety of a single dose of AZD1390 | Number of participants with abnormal ECG and measurement of heart rate, PR QRS, QT and QTcF intervals (in milliseconds) | 6 weeks |
| The safety of a single dose of AZD1390 | Number of participants with abnormal vital signs based on assessment of body temperature, pulse rate, and blood pressure completed with automated devices. | 6 weeks |
| The safety of a single dose of AZD1390 | Assessment of weight (measurement units can be variable) throughout the study. | 6 weeks |
| The safety of a single dose of AZD1390 | Number of participants with abnormal physical examination based on assessment of general appearance, respiratory, cardiovascular, abdomen, skin, head and neck, lymph nodes, thyroid, musculoskeletal, and neurological systems. | 6 weeks |
| Liverpool |
| L7 8XP |
| United Kingdom |
| D009373 |
| Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |