Effect of Itraconazole on the Pharmacokinetics of Apatinib

NCT02836171 | Completed Phase 1

• 1 other identifier: HR-APTN-DDI-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration versus time curve (AUC) of Apatinib

  0~72h after apatinib administration

Secondary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From first administration to the seventh day after last administration

• Peak Plasma Concentration (Cmax) of Apatinib

  0~72h after apatinib administration

Study Arms (1)

Treatment

EXPERIMENTAL

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; Drug: Itraconazole Capsules

Interventions

Apatinib Mesylate Tablets DRUG

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

Also known as: apatinib

Treatment

Itraconazole Capsules DRUG

rifampicin was administered in the morning 0.5 hours after breakfast

Also known as: itraconazole

Treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female of non-childbearing potential or male;
• age 18-45 years;
• body mass index 19-24 kg/m2 with total body weight;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

apatinib; Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Chen Yu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 18, 2016
• Study Start: July 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 27, 2017

Record last verified: 2016-07

Locations

CN (1)