Drug-Drug Interaction Study of Atumelnant in Healthy Participants
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-55
SponsorCrinetics Pharmaceuticals Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Atumelnant
- Carbamazepine
- Midazolam
- Digoxin
- Metformin
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov