- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Nebraska
-
Lincoln, Nebraska, Förenta staterna, 68502
- Crinetics Study Site
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Cohort 1
atumelnant, carbamazepine (CYP3A4 Inducer)
|
Atumelnant, tablets
Andra namn:
CYP3A4 inducer
|
|
Experimentell: Cohort 2
atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate)
|
P-gp substrat
Atumelnant, tablets
Andra namn:
CYP3A4 substrate
MATE1/2-K substrate
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cohort 1: Pharmacokinetics (AUC 0-last)
Tidsram: Up to Day 34
|
Up to Day 34
|
|
Cohort 1: Pharmacokinetics (AUC 0-inf)
Tidsram: Up to Day 34
|
Up to Day 34
|
|
Cohort 1: Pharmacokinetics (Cmax)
Tidsram: Up to Day 34
|
Up to Day 34
|
|
Cohort 2: Pharmacokinetics (AUC 0-last)
Tidsram: Up to Day 21
|
Up to Day 21
|
|
Cohort 2: Pharmacokinetics (AUC 0-inf)
Tidsram: Up to Day 21
|
Up to Day 21
|
|
Cohort 2: Pharmacokinetics (Cmax)
Tidsram: Up to Day 21
|
Up to Day 21
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Cohort 1: Number of participants with Treatment Emergent Adverse Events
Tidsram: Up to Day 34
|
Up to Day 34
|
|
Cohort 2: Number of participants with Treatment Emergent Adverse Events
Tidsram: Up to Day 21
|
Up to Day 21
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Organiska kemikalier
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Kolhydrater
- Polycykliska föreningar
- Glykosider
- Steroider
- Fusion-ringföreningar
- Benzazepiner
- Biguanider
- Guanidiner
- Amidiner
- Bensodiazepiner
- Dibenzazepiner
- Heterocykliska föreningar, 3-ring
- Digitalis glykosider
- Gardenolider
- Hjärtglykosider
- Kardanolider
- Midazolam
- Digoxin
- Metformin
- Karbamazepin
Andra studie-ID-nummer
- CRN04894-131
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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