NCT05265338

A Food Effect Study of KC1036 in Healthy Subjects

A Phase I Study of KC1036 on Pharmacokinetics to Assess the Effect of High Fat Diet in Chinese Adult Healthy Subjects.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study was to assess the effect of High Fat Diet on the pharmacokinetics of KC1036 in Chinese adult healthy subjects.

Detailed description

This is an open-label, randomized, two cycle self crossover experimental design study to assess the effect of High Fat Diet on the pharmacokinetics, material balance, safety of KC1036 in Chinese adult healthy subjects. This study was divided into two Groups A and B. Group A：In the fasting state, KC1036 po only once (60mg QD) and after 7 days, in the high fat diet state, KC1036 po only once (60mg QD). Group B：In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	KC1036	60mg QD

Timeline

• Start date: 2022-03-10
• Primary completion: 2022-03-23
• Completion: 2022-03-23
• First posted: 2022-03-03
• Last updated: 2023-10-10

Locations

1 site across 1 country: China