NCT04584515

IMP4297 DDI (Drug-Drug Interaction)Trial in Healthy Male Volunteers

A Phase I, Open-label, Fixed-Sequence Study to Evaluate the Effect of Multiple-dose Itraconazole or Rifampicin Capsules on the Single-dose PK (Pharmacokinetics) Profiles of IMP4297 Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Impact Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase I, Open-label, Fixed-Sequence Study to Evaluate the Effect of Multiple-dose Itraconazole or Rifampicin Capsules on the Single-dose PK Profiles of IMP4297 Capsules in Healthy Subjects

Detailed description

Study design A Phase I, single-center, open-label, fixed-sequence study is designed to evaluate the effect of multiple-dose Itraconazole or Rifampicin Capsules on the single-dose PK profiles of IMP4297 Capsules in healthy Chinese subjects. 32 subjects are planned to be enrolled (at least 12 subjects complete the study on one side). Two parallel groups will be planned in this study with 16 subjects enrolled in each group. Two cycles are set for each group. The first group will be given IMP4297 and Itraconazole in a fixed sequence (two dosing regimens); The second group will receive IMP4297 and Rifampicin in a fixed sequence (two dosing regimens).

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	IMP4297 40 mg	IMP4297 40 mg: IMP4297 alone, Itraconazole + IMP4297
DRUG	IMP4297 100 mg	IMP4297 100 mg: IMP4297 alone, Rifampin + IMP4297

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-03-08
• Completion: 2021-05-27
• First posted: 2020-10-14
• Last updated: 2021-08-24

Locations

1 site across 1 country: China