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
Abstract
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.
Conditions: Healthy Volunteers.
Primary outcome: Cohort 1: Pharmacokinetics (AUC 0-last); Cohort 1: Pharmacokinetics (AUC 0-inf); Cohort 1: Pharmacokinetics (Cmax); Cohort 2: Pharmacokinetics (AUC 0-last); Cohort 2: Pharmacokinetics (AUC 0-inf); Cohort 2: Pharmacokinetics (Cmax).
Enrollment: 46 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 46 participants or records.
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