NCT06126562

A Pharmacokinetic Study of Lanifibranor in Healthy Adult Chinese Subjects

A Phase I Clinical Study to Evaluate the Pharmacokinetic Profile and Safety of Lanifibranor After Single Dose and Multiple Doses in Healthy Adult Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This will be a randomized, open-label parallel design and single centre study conducted at the 1st hospital affiliated to Jilin University. Approximately 24 healthy Chinese volunteers, male and female will be recruited and divided into two equal groups (12 subjects per dose). The primary objective of this study is to evaluate the pharmacokinetic profile of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects. The secondary objective is to evaluate the safety of lanifibranor after single dose and multiple doses 800 and 1200 mg in healthy adult Chinese subjects.

Conditions

• Pharmacokinetic

Interventions

Type	Name	Description
DRUG	Lanifibranor	Lanifibranor is a pan-peroxisome proliferator-activated receptor (PPAR) agonist.

Timeline

• Start date: 2023-10-31
• Primary completion: 2023-11-28
• Completion: 2023-12-15
• First posted: 2023-11-13
• Last updated: 2024-01-02

Locations

1 site across 1 country: China