Drug-Drug Interaction Study of Atumelnant in Healthy Participants

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Crinetics Pharmaceuticals Inc.
Study ID
NCT07570082
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Atumelnant — DRUG
    Atumelnant, tablets
  • Carbamazepine — DRUG
    CYP3A4 inducer
  • Midazolam — DRUG
    CYP3A4 substrate
  • Digoxin — DRUG
    P-gp substrate
  • Metformin — DRUG
    MATE1/2-K substrate

Study Details

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.

Key Dates

Start date
May 6, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    atumelnant, carbamazepine (CYP3A4 Inducer)
  • Experimental: Cohort 2
    atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate)

Primary Outcome Measure

Cohort 1: Pharmacokinetics (AUC 0-last) [ Time Frame: Up to Day 34 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Crinetics Study SiteLincolnNebraska68502-

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By research site
Crinetics Study Site· Lincoln, NE

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