A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and the Absolute Bioavailability of AZD4954
4. september 2026 oppdatert av: AstraZeneca
An Open-Label Study to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD4954 and Absolute Bioavailability of AZD4954 in Healthy Male Participants
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 two-part study will take place at one site in Nottingham, United Kingdom, and will enroll 8 healthy men in each part, aged 30-65 years.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Detaljert beskrivelse
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 8 healthy male participants in each part, aged 30-65 years.
In part 1 volunteers will receive a single dose of radiolabelled test medicine as a liquid by mouth. They'll stay in the clinic for up to 24 nights, attend 1 outpatient visit, and take up to 8 weeks to finish the study.
In part 2 volunteers will receive a single dose of test medicine by mouth and, shortly afterwards, a very tiny dose of radiolabelled study medicine by injection into a vein. They'll stay in the clinic for up to 15 nights, attend 1 outpatient visit, 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.
Studietype
Intervensjonell
Registrering (Antatt)
16
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Healthy males aged 30 to 65 years inclusive
- BMI of 18.0 to 35.0 kg/m2 inclusive
- Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day)
Exclusion Criteria:
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment
- History of clinically significant cardiovascular, renal, hepatic, respiratory, dermatological or gastrointestinal disease, and neurological or psychiatric disorder
- History of cholecystectomy or gall stones
- History of GI surgery
- Acute diarrhoea or constipation in the 7 days before the predicted Day 1
- Participants who do not have suitable veins for multiple venepunctures/cannulation
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis
- Evidence of renal impairment at screening
- Participants who have received any IMP in a clinical research study within the 90 days prior to Day 1
- Participants who have previously been administered IMP in this study
- Radiation exposure exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years
- Participants who have been administered IMP in an ADME study in the last 12 months
- Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
- Use of any prescribed or non-prescribed medication including antacids, gastric pH modifying agents, analgesics, herbal remedies, vitamins and minerals within 2 weeks of dosing
- Current smokers or known or suspected history of alcohol or drug abuse
- Excessive intake of caffeine-containing drinks or food
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Part 1
Participants in Part 1 will receive a single dose of [14C]AZD4954 Oral Solution.
|
Participants in Part 1 will recieve a single dose of [14C]AZD4954 oral solution
|
|
Eksperimentell: Part 2
Participants in Part 2 will receive a single unlabelled oral dose of AZD4954 tablet and a radiolabelled IV microtracer dose of [14C]AZD4954.
|
Participants in Part 2 will receive a single dose of AZD4954 film-coated tablet by mouth
Participants in Part 2 will receive a single very tiny dose of radiolabelled [14C]AZD4954 Solution for Infusion as a slow injection into a vein
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Amount of AZD4954 excreted (Ae) (Part 1)
Tidsramme: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
|
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
|
Amount of AZD4954 excreted expressed as a fraction of dose excreted (Fe) (Part 1)
Tidsramme: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
|
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
|
Cumulative amount of AZD4954 excreted (CumAe) (Part 1)
Tidsramme: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
|
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
|
Cumulative amount of AZD4954 excreted expressed as a fraction of dose excreted (CumFe) (Part 1)
Tidsramme: Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Mass balance recovery, rates and routes of elimination of total radioactivity of [14C] AZD4954 in urine, faeces and all excreta
|
Urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
|
Absolute bioavailability (F) based on AUC0-inf (Part 2)
Tidsramme: Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
|
Absolute bioavailability of AZD4954 oral and IV administration, adjusted for dose
|
Plasma, urine and faecal samples from pre-dose until up to 336 hours post-dose
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum observed concentration (Cmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Tidsramme: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 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 552 hours post-dose
|
|
Time of maximum observed concentration (Tmax) for AZD4954 and total radioactivity (Parts 1 and 2)
Tidsramme: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 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 552 hours post-dose
|
|
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for AZD4954 and total radioactivity (Parts 1 and 2)
Tidsramme: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 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 552 hours post-dose
|
|
Terminal elimination half-life (T1/2) for AZD4954 and total radioactivity (Parts 1 and 2)
Tidsramme: Plasma, urine, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
The PK of AZD4954 and [14C]AZD4954 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 552 hours post-dose
|
|
Area under the curve (AUC) of circulating total radioactivity accounting for 10% or more of the dose (Part 1)
Tidsramme: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Identification of the chemical structure of each metabolite
|
Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
|
80% or more of the radioactivity recovered in excreta (Part 1)
Tidsramme: Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
Identification of the chemical structure of each metabolite
|
Plasma, urine and faecal samples collected from pre-dose until up to 552 hours post-dose
|
|
Disposition of total radioactivity in plasma and in blood (Part 1)
Tidsramme: Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
Evaluation of whole blood:plasma concentration ratios for total radioactivity
|
Plasma, and whole blood samples collected from pre-dose until up to 552 hours post-dose
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sharan Sidhu, MBChB, BAO, MRCS, MFPM, Quotient Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
19. oktober 2026
Primær fullføring (Antatt)
17. desember 2026
Studiet fullført (Antatt)
17. desember 2026
Datoer for studieregistrering
Først innsendt
4. september 2026
Først innsendt som oppfylte QC-kriteriene
4. september 2026
Først lagt ut (Faktiske)
10. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. september 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- D7300C00005
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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 athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Tilgangskriterier for IPD-deling
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org.
Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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