NCT07221084

A Study to Assess Pharmacokinetics, Safety, and Tolerability of Atumelnant in Healthy Japanese and Caucasian Participants

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess Pharmacokinetics, Safety, and Tolerability of Atumelnant in Healthy Japanese and Caucasian Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the PK profile, safety, and tolerability of atumelnant after single and multiple once daily (QD) oral doses in healthy Japanese and Caucasian adult participants.

Detailed description

This is a Phase 1, stratified randomized, double-blind, placebo-controlled, 2-cohort, 2-period, fixed-sequence study to assess the PK profile, safety, and tolerability of atumelnant after single and multiple QD oral doses in healthy Japanese and Caucasian adult participants. Approximately 20 healthy male and female participants of either Japanese or Caucasian ethnicities will be enrolled in the study to receive the study intervention.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Atumelnant	Atumelnant, tablets, once daily by mouth
DRUG	Placebo	Placebo, tablets, once daily by mouth

Timeline

• Start date: 2025-10-28
• Primary completion: 2026-02-07
• Completion: 2026-02-27
• First posted: 2025-10-27
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study