Effect of Itraconazole on the Pharmacokinetics of Apatinib

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Apatinib Mesylate Tablets; Drug: Itraconazole Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02836171

HR-APTN-DDI-03

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment

Experimental group

Description:

subjects receiving a single 250 mg oral dose of apatinib mesylate tablets and wash-out for 3 days,then Itraconazole capsules 100 mg/day orally for 6 days with a single 250 mg oral dose of apatinib mesylate tablets co-administered on day 4 . apatinib mesylate tablets was administered in the morning after an overnight fast of at least 10 h

Treatment:

Drug: Itraconazole Capsules

Drug: Apatinib Mesylate Tablets