Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Atumelnant

    Drug

    Atumelnant, tablets

  • Carbamazepine

    Drug

    CYP3A4 inducer

  • Midazolam

    Drug

    CYP3A4 substrate

  • Digoxin

    Drug

    P-gp substrate

  • Metformin

    Drug

    MATE1/2-K substrate

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Cohort 1Experimental treatment 2 interventions
Group B: Cohort 2Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Cohort 1: Pharmacokinetics (AUC 0-last)

Time frame
Up to Day 34
2

Cohort 1: Pharmacokinetics (AUC 0-inf)

Time frame
Up to Day 34
3

Cohort 1: Pharmacokinetics (Cmax)

Time frame
Up to Day 34
4

Cohort 2: Pharmacokinetics (AUC 0-last)

Time frame
Up to Day 21

Secondary outcomes

1

Cohort 1: Number of participants with Treatment Emergent Adverse Events

Time frame
Up to Day 34
2

Cohort 2: Number of participants with Treatment Emergent Adverse Events

Time frame
Up to Day 21

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Crinetics Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
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