Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Drug-Drug Interaction Study of Atumelnant in Healthy Participants

29. april 2026 opdateret af: Crinetics Pharmaceuticals Inc.

A Phase 1, Open-Label, Two-Cohort Study to Assess the Effect of a Strong CYP3A4 Inducer on the Pharmacokinetics of Atumelnant and the Effect of Atumelnant on the Pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in Healthy Participants

This study aims to evaluate the impact of strong CYP3A4 induction on the pharmacokinetics (PK) of atumelnant, as well as the effect of atumelnant on CYP3A4, P-gp, and MATE1/2-K substrates in healthy participants.

Studieoversigt

Detaljeret beskrivelse

This is a Phase 1, open-label, two-Cohort Study to assess the effect of a strong CYP3A4 inducer on the pharmacokinetics of atumelnant and the effect of atumelnant on the pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in healthy participants.

Approximately 20 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 1. Approximately 26 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 2.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

46

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68502
        • Rekruttering
        • Crinetics Study Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Healthy adult females of non-childbearing potential (Section 14.2) or healthy adult males, 19-55 years of age, inclusive, at the screening visit.
  2. BMI ≥18.0 and ≤32.0 kg/m2 at the screening visit.
  3. Is willing and able to comply with all study procedures and restrictions, including fasting and consumption of protocol-specified standardized meal for required study measurements; inpatient admission; follow-up contact; receipt of rescue therapy, if necessary; abstinence from tobacco, alcohol, drugs, and from strenuous unaccustomed exercise and sports (defined as greater than 30 minutes per day) during the study period.
  4. Normal adrenocorticotropic hormone (ACTH)-stimulated cortisol test at the screening visit and does not have signs and symptoms of adrenal insufficiency as deemed by the PI or designee.

Exclusion Criteria:

  1. 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.
  2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
  3. Female participant with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
  4. Female participant of childbearing potential.
  5. Had prior treatment with atumelnant.
  6. Participation in another clinical study within 30 days or received any investigational drug within 5 half-lives prior to the first dosing, whichever is longer. The time window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
  7. History or presence of hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.
  8. Has a blood loss ≥500 mL or donated blood within 3 months prior to the first dosing.
  9. Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, vitamin supplements, or other food supplements within 14 days or 5 half-lives prior to the first dosing, whichever is longer.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1
atumelnant, carbamazepine (CYP3A4 Inducer)
Atumelnant, tablets
Andre navne:
  • CRN04894
CYP3A4 inducer
Eksperimentel: Cohort 2
atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate)
P-gp substrat
Atumelnant, tablets
Andre navne:
  • CRN04894
CYP3A4 substrate
MATE1/2-K substrate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Cohort 1: Pharmacokinetics (AUC 0-last)
Tidsramme: Up to Day 34
Up to Day 34
Cohort 1: Pharmacokinetics (AUC 0-inf)
Tidsramme: Up to Day 34
Up to Day 34
Cohort 1: Pharmacokinetics (Cmax)
Tidsramme: Up to Day 34
Up to Day 34
Cohort 2: Pharmacokinetics (AUC 0-last)
Tidsramme: Up to Day 21
Up to Day 21
Cohort 2: Pharmacokinetics (AUC 0-inf)
Tidsramme: Up to Day 21
Up to Day 21
Cohort 2: Pharmacokinetics (Cmax)
Tidsramme: Up to Day 21
Up to Day 21

Sekundære resultatmål

Resultatmål
Tidsramme
Cohort 1: Number of participants with Treatment Emergent Adverse Events
Tidsramme: Up to Day 34
Up to Day 34
Cohort 2: Number of participants with Treatment Emergent Adverse Events
Tidsramme: Up to Day 21
Up to Day 21

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

6. maj 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. december 2026

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Digoxin

Abonner