Effect of Itraconazole on the Pharmacokinetics of Apatinib

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ClinicalTrials.gov Identifier: NCT02836171

Recruitment Status : Completed

First Posted : July 18, 2016

Last Update Posted : February 27, 2017

Sponsor:

Information provided by (Responsible Party):

Jiangsu HengRui Medicine Co., Ltd.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Neoplasms	Drug: Apatinib Mesylate Tablets Drug: Itraconazole Capsules	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of Itraconazole on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers
Study Start Date :	July 2016
Actual Primary Completion Date :	February 2017
Actual Study Completion Date :	February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Itraconazole

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment 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	Drug: Apatinib Mesylate Tablets apatinib was administered in the morning after an overnight fast of at least 10 h Other Name: apatinib Drug: Itraconazole Capsules rifampicin was administered in the morning 0.5 hours after breakfast Other Name: itraconazole

Outcome Measures

Primary Outcome Measures :

Area under the plasma concentration versus time curve (AUC) of Apatinib [ Time Frame: 0~72h after apatinib administration ]

Secondary Outcome Measures :

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From first administration to the seventh day after last administration ]
Peak Plasma Concentration (Cmax) of Apatinib [ Time Frame: 0~72h after apatinib administration ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836171

Locations

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China, Shanghai
Shanghai Xuhui Central Hospital
Shanghai, Shanghai, China, 200030

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

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Principal Investigator:	Chen Yu	Shanghai Xuhui Central Hospital

More Information

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Responsible Party:	Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:	NCT02836171
Other Study ID Numbers:	HR-APTN-DDI-03
First Posted:	July 18, 2016 Key Record Dates
Last Update Posted:	February 27, 2017
Last Verified:	July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Additional relevant MeSH terms:

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Itraconazole Hydroxyitraconazole Apatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents	Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors

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