NeoplasmsPhase 1NCT02836171
Effect of Itraconazole on the Pharmacokinetics of Apatinib
A Phase 1 study testing Apatinib Mesylate Tablets and Itraconazole Capsules in people with Neoplasms, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- Apatinib Mesylate Tablets and Itraconazole Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- female of non-childbearing potential or male;
- age 18-45 years;
- body mass index 19-24 kg/m2 with total body weight;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Effect of Itraconazole on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers
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
- Being tested
- Apatinib Mesylate Tablets, Itraconazole Capsules
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib Mesylate TabletsDrug
Also called apatinib
apatinib was administered in the morning after an overnight fast of at least 10 h
Itraconazole CapsulesDrug
Also called itraconazole
rifampicin was administered in the morning 0.5 hours after breakfast
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Apatinib Mesylate Tablets; Drug: Itraconazole Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of Apatinib
Measured: 0~72h after apatinib administration
Secondary outcomes (2)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From first administration to the seventh day after last administration
Peak Plasma Concentration (Cmax) of Apatinib
Measured: 0~72h after apatinib administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Yu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836171
- Sponsor's protocol ID
- HR-APTN-DDI-03
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 27 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Itraconazole on the Pharmacokinetics of Apatinib in Chinese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02836171
- Acronym / sponsor ID
- HR-APTN-DDI-03
- Conditions
- Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Apatinib Mesylate Tablets, Drug: Itraconazole Capsulessubjects 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female of non-childbearing potential or male;
- age 18-45 years;
- body mass index 19-24 kg/m2 with total body weight;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib Mesylate TabletsAlso: apatinibapatinib was administered in the morning after an overnight fast of at least 10 h | Drug | Treatment |
| Itraconazole CapsulesAlso: itraconazolerifampicin was administered in the morning 0.5 hours after breakfast | Drug | Treatment |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of Apatinib
Time frame: 0~72h after apatinib administration
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen Yu principal investigator
Xuhui Central Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apatinib Mesylate Tablets and Itraconazole Capsules in people with Neoplasms, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) of Apatinib (time frame: 0~72h after apatinib administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.