Effect of Rifampicin on the Pharmacokinetics of Apatinib

NCT ID: NCT02836821

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-02-28

Brief Summary

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

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Apatinib

subjects receiving a single 750 mg oral dose of apatinib mesylate tablets and wash-out for 3 days,then rifampicin capsules 600 mg/day orally for 10 days with a single 750 mg oral dose of apatinib mesylate tablets co-administered on day 8 . apatinib mesylate tablets was administered in the morning after an overnight fast of at least 10 h

Group Type: EXPERIMENTAL

Apatinib Mesylate Tablets

Intervention Type: DRUG

apatinib was administered in the morning after an overnight fast of at least 10 h

Rifampicin Capsules

Intervention Type: DRUG

rifampicin was administered in the morning 2 hours after breakfast

Interventions

Apatinib Mesylate Tablets

apatinib was administered in the morning after an overnight fast of at least 10 h

Intervention Type: DRUG

Rifampicin Capsules

rifampicin was administered in the morning 2 hours after breakfast

Intervention Type: DRUG

Other Intervention Names

apatinib; rifampin

Eligibility 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 significant 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

HR-APTN-DDI-02

Identifier Type: -

Identifier Source: org_study_id