Effect of Itraconazole on the Pharmacokinetics of Apatinib

Neoplasms Clinical Trial

Official title:

Effect of Itraconazole on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836171
• Other study ID #: HR-APTN-DDI-03
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2016
• Last updated: February 23, 2017
• Start date: July 2016
• Est. completion date: February 2017

Study information

• Verified date: July 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Apatinib Mesylate Tablets
apatinib was administered in the morning after an overnight fast of at least 10 h
• Itraconazole Capsules
rifampicin was administered in the morning 0.5 hours after breakfast

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of Apatinib		0~72h after apatinib administration
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		From first administration to the seventh day after last administration
Secondary	Peak Plasma Concentration (Cmax) of Apatinib		0~72h after apatinib administration