A Phase I Study to Assess the Effect of Itraconazole and Rifampicin on Pharmacokinetics Profile of BPI-7711

• Status: Completed
• Trial end date: 2020-07-22
• Target enrollment: 0
• Participant gender: Male

Summary

This is a phase I study to assess the effect of itraconazole and rifampicin on the pharmacokinetic parameters of BPI-7711 in Chinese healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beta Pharma, Inc.
• Treatments: Hydroxyitraconazole; Itraconazole; Rifampin

Criteria

Inclusion Criteria:

• Male, aged from 18 to 45 years

• BMI from 18.5 to 28.0 kg/m2

• Medical history, vital signs, physical examination and lab tests are normal or abnormal without clinical significance

Exclusion Criteria:

• Subjects with clinical significant diseases

• Subjects with allergic disease history

• Subjects with gastrointestinal disease history that can affect study drug absorption

• Subjects with drug abuse history