NCT05069870

A Study to Investigate the Drug-drug Interactions (DDIs) of SKLB1028 With Itraconazole, Gemfibrozil or Rifampicin in Healthy Subjects

A Three-part, Single-center, Open-label, Phase I Drug-drug Interaction Clinical Study to Investigate the Effect of Itraconazole, Gemfibrozil or Rifampicin on Pharmacokinetics of SKLB1028 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a three-part, single-center, open-label phase I clinical study to characterize the DDIs potential of SKLB1028 with Itraconazole, Gemfibrozil or Rifampicin in healthy subjects. This study also aims to evaluate the safety and tolerability of SKLB1028 in the presence of Itraconazole, Gemfibrozil or Rifampicin.

Detailed description

SKLB1028 is the potential substrate of CYP3A4, CYP2C8 and P-gp. This study conducted in three parts to characterize the DDIs potential of SKLB1028 with the perpetrator drugs ( Itraconazole, Gemfibrozil, Rifampicin) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SKLB1028	SKLB1028, capsule, oral
DRUG	Itraconazole	Itraconazole, capsule, oral
DRUG	Gemfibrozil	Gemfibrozil, capsule, oral
DRUG	Rifampicin	Rifampicin, capsule, oral

Timeline

• Start date: 2021-06-07
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2021-10-06
• Last updated: 2021-10-06

Locations

1 site across 1 country: China