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Completed

NCT Number: NCT02836821

Effect of Rifampicin on the Pharmacokinetics of Apatinib

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.

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Key information

Conditions

Neoplasms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apatinib Mesylate Tablets

Drug

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

Other names: apatinib

Rifampicin Capsules

Drug

rifampicin was administered in the morning 2 hours after breakfast

Other names: rifampin

Primary outcomes

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

    Time frame: 0~72h after apatinib administration

Secondary outcomes

  1. 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

  2. Peak Plasma Concentration (Cmax) of Apatinib

    Time frame: 0~72h after apatinib administration

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Feb 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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