- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07641881
A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants
A Phase 1, Open-Label, Randomized, Single-Dose, Three-Treatment, Three-Period, Six-Sequence Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of Two Casdatifan (AB521) Tablet Strengths and Food Effect in Healthy Adult Participants
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
Arizona
-
Tempe, Arizona, Forente stater, 85283
- Research Site
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
- BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg at the screening visit.
- Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
- Able to swallow multiple tablets.
- Has adequate peripheral venous access.
Exclusion Criteria:
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
- Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI or designee considers to be clinically significant.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Treatment A
Participants will receive 4 X 25 mg tablets of casdatifan.
|
Administrert som spesifisert i behandlingsarmen
Andre navn:
|
|
Eksperimentell: Treatment B
Participants will receive 1 X 100 mg tablets of casdatifan.
|
Administrert som spesifisert i behandlingsarmen
Andre navn:
|
|
Eksperimentell: Treatment C
Participants will receive 4 X 25 mg tablets of casdatifan under fed conditions.
|
Administrert som spesifisert i behandlingsarmen
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Maximum observed concentration for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
|
Area under the concentration-time curve for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Time to reach Cmax (Tmax) for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
|
Lag time (Tlag) for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
|
Apparent first-order terminal elimination rate constant (Kel) for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
|
Percent of AUC0-inf extrapolated for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
|
Apparent first-order terminal elimination half-life (t½) for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
|
Apparent total clearance after extravascular (oral) administration (CL/F) for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
|
Apparent total clearance after extravascular (oral) administration (Vz/F) for casdatifan
Tidsramme: Up to 168 hours post each dose
|
Up to 168 hours post each dose
|
|
Number of participants experiencing Adverse Events (AEs)
Tidsramme: Up to 43 days
|
Up to 43 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Medical Director, Arcus Biosciences
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ARC-30
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
For more information, please visit our website.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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