Effect of Itraconazole on the Pharmacokinetics of Apatinib

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

he primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with itraconazole. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with itraconazole.

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

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Apatinib; Hydroxyitraconazole; Itraconazole

Criteria

Inclusion Criteria:

• female of non-childbearing potential or male;

• age 18-45 years;

• body mass index 19-24 kg/m2 with total body weight;

Exclusion Criteria:

• clinically signiWcant medical or surgical conditions with the potential to interfere with the absorption, distribution, metabolism or excretion of the study drugs;

• history of alcohol abuse; smoker;

• electrocardiogram(ECG) abnormality;

• blood pressure >140/90 mmHg;

• treatment with an investigational drug or any known CYP450 enzyme inducing/-inhibiting agents or herbal supplements within 14 days prior to first dose of study medication;

• Subjects were to abstain from using prescription and non-prescription drugs (other than acetaminophen as deemed necessary), vitamins and dietary supplements within 14 days prior to the first dose of study medication and throughout the study.