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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
single dose
Research Site
Guildford, United Kingdom
Research Site
Liverpool, United Kingdom
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount excreted (Ae) (urine)
Time frame: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount excreted (CumAe) (urine)
Time frame: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount excreted (Ae) (feaces)
Time frame: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount excreted (CumAe) (feaces)
Time frame: 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)
Time frame: 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)
Time frame: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount (percentage) excreted (Fe) (urine)
Time frame: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount (percentage) excreted (CumFe) (urine)
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Time frame: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Amount (percentage) excreted (Fe) (feaces)
Time frame: 6 Weeks
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Cumulative Amount (percentage) excreted (CumAe) (feaces)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 )
Time frame: 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 )
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Analysis of urine: Cumulative amount excreted (CumAe)
Time frame: 6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Analysis of urine: Fraction (percentage) excreted (Fe)
Time frame: 6 weeks
The distribution of total radioactivity into blood cells after a single oral dose
Analysis of urine: Fraction (percentage) excreted (Fe)
Time frame: 6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
Time frame: 6 weeks
Pharmacokinetic(s) of AZD1390 after a single oral dose
Analysis of urine: Renal clearance (CLR)
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Maximum observed concentration (Cmax)
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
Time frame: 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)
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
Time frame: 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 )
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: 6 weeks
The phamrmacokinetic(s) of AZD1390 metabolite
Analysis of metabolite in plasma: parent ratio
Time frame: 6 weeks
Metabolic profiling following single oral dose of AZD1390
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 6 weeks
The safety of a single dose of AZD1390
Assessment of weight (measurement units can be variable) throughout the study.
Time frame: 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.
Time frame: 6 weeks