- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07570082
Drug-Drug Interaction Study of Atumelnant in Healthy Participants
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
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
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Crinetics Clinical Trials
- Telefonnummer: 833-827-9741
- E-mail: clinicaltrials@crinetics.com
Studiesteder
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater, 68502
- Rekruttering
- Crinetics Study Site
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Healthy adult females of non-childbearing potential (Section 14.2) or healthy adult males, 19-55 years of age, inclusive, at the screening visit.
- BMI ≥18.0 and ≤32.0 kg/m2 at the screening visit.
- 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.
- 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:
- 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 or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- Female participant with a positive pregnancy test at the screening visit or at first check-in or who is lactating.
- Female participant of childbearing potential.
- Had prior treatment with atumelnant.
- 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.
- History or presence of hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.
- Has a blood loss ≥500 mL or donated blood within 3 months prior to the first dosing.
- 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
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:
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:
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
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulhydrater
- Polycykliske forbindelser
- Glycosider
- Steroider
- SMUSED-RING-forbindelser
- Benzazepiner
- Biguanides
- Guanidiner
- Amidiner
- Benzodiazepiner
- Dibenzazepiner
- Heterocykliske forbindelser, 3-ring
- Digitalis glycosider
- Cardenolider
- Hjerte glycosider
- Cardanolider
- Midazolam
- Digoxin
- Metformin
- Carbamazepin
Andre undersøgelses-id-numre
- CRN04894-131
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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