This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of \[14C\]-AZD1390.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria:
* Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,
* ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,
* Predicted life expectancy ≥ 12 weeks,
* Adequate organ and marrow function,
* Creatinine clearance ≥ 50 mL/min,
* Regular bowel movements,
* No cancer-associated cachexia (weight loss).
Exclusion Criteria:
* History or presence of myopathy or raised CK \> 5 × ULN at screening,
* History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,
* History or presence of clinically significant hepatic disease,
* History of epileptic disorder or any seizure history unrelated to tumour,
* History of MDS/AML or with features suggestive of MDS/AML,
* Predisposition to bleeding
* History of persisting (\> 2 weeks) severe cytopenia
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection
* History of another primary malignancy
* Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy,
* Spinal cord compression or brain metastases for at least 4 weeks
Primary outcome measure(s)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Amount excreted (Ae) (urine)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Cumulative Amount excreted (CumAe) (urine)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Amount excreted (Ae) (feaces)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Cumulative Amount excreted (CumAe) (feaces)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Amount excreted (Ae) (total - urine and feaces combined)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Cumulative Amount excreted (CumAe) (total urine and feaces combined)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Amount (percentage) excreted (Fe) (urine)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Cumulative Amount (percentage) excreted (CumFe) (urine)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Amount (percentage) excreted (Fe) (feaces)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Cumulative Amount (percentage) excreted (CumAe) (feaces)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Amount (percentage) excreted (Fe) (total urine and faeces combined)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined)
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose — 6 Weeks If emesis occurs, vomitus will be analysed for total radioactivity
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Maximum observed concentration (Cmax)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis whole blood: Maximum observed concentration (Cmax)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity
Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity
Pharmacokinetic(s) of AZD1390 after a single oral dose — 6 weeks Analysis of urine: Cumulative amount excreted (CumAe)
Pharmacokinetic(s) of AZD1390 after a single oral dose — 6 weeks Analysis of urine: Fraction (percentage) excreted (Fe)
The distribution of total radioactivity into blood cells after a single oral dose — 6 weeks Analysis of urine: Fraction (percentage) excreted (Fe)
Pharmacokinetic(s) of AZD1390 after a single oral dose — 6 weeks Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
Pharmacokinetic(s) of AZD1390 after a single oral dose — 6 weeks Analysis of urine: Renal clearance (CLR)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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