Human ADME Study of [14C]-AZD1390
keskiviikko 10. kesäkuuta 2026 päivittänyt: AstraZeneca
A Phase I, Open-label Study to Assess the Absorption, Distribution, Metabolism, and Excretion (ADME) of AZD1390 After a Single Oral Dose of [14C]-AZD1390 in Participants With Advanced Solid Malignancies
This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of [14C]-AZD1390.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
8
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: AstraZeneca Clinical Study Information Center
- Puhelinnumero: 1-877-240-9479
- Sähköposti: information.center@astrazeneca.com
Opiskelupaikat
-
-
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Guildford, Yhdistynyt kuningaskunta, GU2 7WG
- Research Site
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Liverpool, Yhdistynyt kuningaskunta, L7 8XP
- Research Site
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-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: AZD1390
Single dose of [14C]-AZD1390
|
single dose
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
Amount excreted (Ae) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
Cumulative Amount excreted (CumAe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
Amount excreted (Ae) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
Cumulative Amount excreted (CumAe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
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
Aikaikkuna: 6 Weeks
|
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
Aikaikkuna: 6 Weeks
|
Amount (percentage) excreted (Fe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
Cumulative Amount (percentage) excreted (CumFe) (urine)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
Amount (percentage) excreted (Fe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
Cumulative Amount (percentage) excreted (CumAe) (feaces)
|
6 Weeks
|
|
The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose
Aikaikkuna: 6 Weeks
|
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
Aikaikkuna: 6 Weeks
|
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
Aikaikkuna: 6 Weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
Analysis of urine: Cumulative amount excreted (CumAe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Aikaikkuna: 6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
The distribution of total radioactivity into blood cells after a single oral dose
Aikaikkuna: 6 weeks
|
Analysis of urine: Fraction (percentage) excreted (Fe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Aikaikkuna: 6 weeks
|
Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)
|
6 weeks
|
|
Pharmacokinetic(s) of AZD1390 after a single oral dose
Aikaikkuna: 6 weeks
|
Analysis of urine: Renal clearance (CLR)
|
6 weeks
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Aikaikkuna: 6 weeks
|
Analysis of plasma: Maximum observed concentration (Cmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Aikaikkuna: 6 weeks
|
Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Aikaikkuna: 6 weeks
|
Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Aikaikkuna: 6 weeks
|
Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
|
6 weeks
|
|
The phamrmacokinetic(s) of AZD1390 metabolite
Aikaikkuna: 6 weeks
|
Analysis of metabolite in plasma: parent ratio
|
6 weeks
|
|
Metabolic profiling following single oral dose of AZD1390
Aikaikkuna: 6 weeks
|
Quantification and identification of major metabolites of AZD1390 in plasma and excreta.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
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
Aikaikkuna: 6 weeks
|
Assessment of weight (measurement units can be variable) throughout the study.
|
6 weeks
|
|
The safety of a single dose of AZD1390
Aikaikkuna: 6 weeks
|
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
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Tiistai 30. kesäkuuta 2026
Ensisijainen valmistuminen (Arvioitu)
Keskiviikko 12. huhtikuuta 2028
Opintojen valmistuminen (Arvioitu)
Keskiviikko 12. huhtikuuta 2028
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Torstai 18. joulukuuta 2025
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Keskiviikko 10. kesäkuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Perjantai 12. kesäkuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 12. kesäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Keskiviikko 10. kesäkuuta 2026
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- D6940C00006
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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.
IPD-jaon aikakehys
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.
IPD-jaon käyttöoikeuskriteerit
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.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
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