HealthyPhase 1NCT02689752
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion Of [14C] Fruquintinib
A Phase 1 study testing fruquintinib in people with Healthy, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
This will be an open-label, single-center study to evaluate pharmacokinetics and safety of HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of HMPL-013 containing approximately 100 microcuries of [14C] HMPL-013. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fruquintinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Sep 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A Healthy Male Volunteer between 18 and 40 years of age inclusive;
- A Body Mass Index (BMI) within the range of 19 to 25 kg/m2 and a total body weight >50kg;
- Medically normal subjects with no significant abnormal findings at the screening vital signs, physical examination, electrocardiogram (ECG), and laboratory parameters as evaluated by the investigator;
- Fertile male subjects and their partners are willing to undergo contraception as follows: condom, contraceptive sponge, contraceptive gel, contraceptive diaphragm, intrauterine devices, hormonal contraceptives (oral or injectable), subepidermal contraceptive implant and other contraception methods during the study and until 1 year after taking the dose of investigational product,
- Subject must voluntarily consent to participate in this study, provide their written informed consent prior to start of any study- specific procedures and be willing to comply with all study procedures.
Who cannot join
- Subjects who have a family history of coronary heart disease;
- Subjects who have a known history of bleeding such as gingival hemorrhage, epistaxis and hemorrhoid bleeding etc.;
- Subjects have hypertension (Systolic Pressure ≥140 mmHg or Diastolic Pressure ≥90 mmHg);
- Subjects who are taking, or have taken any drugs that affect metabolism or prescription medication during the screening or within 30 days prior to the screening; Subjects who are taking, or have taken any OTC, herbal remedies or Vitamin during the screening or within 14 days prior to the screening; Subjects who are taking, or have taken any plant extracts like Hypericum Perforatum L. which are not therapeutic but have health function and can affect the absorption and metabolism during the screening or within 3 days prior to the screening; Subjects who have participated in another clinical trial within 2 months prior to the screening;
- Subjects who are taking, or have taken any drugs which have toxicity to major organs during the screening or within 3 months prior to the screening;
- Subjects who test positive for nicotine screening or can't quit smoking completely in the study;
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- Subjects who have history or presence of any clinically significant diseases within 3 months prior to the screening;
- Subjects who have history or presence of gastrointestinal, hepatic, renal diseases or any other known condition that can affect the absorption, distribution, metabolism or excretion of the investigational product;
- Subjects who have chronic constipation, diarrhea, irritable bowel syndrome or inflammatory bowel disease;
- Subjects who have hemorrhoids or perianal complications with regular hematochezia;
- Subjects who have a known history of severe allergic reaction such as drug allergy or had an acute allergic rhinitis or food allergy within 14 days prior to the study medication;
- Subjects who have donated blood or plasma more than 500ml within 2 months prior to the study medication or more than 50ml within 14 days prior to the study medication;
- Subjects who have had a positive test for hepatitis B (HBsAg) or hepatitis C (excluded immunization);
- Subjects who have had a positive test for human immunodeficiency virus (HIV);
- Subjects who have taken vaccination during the screening or within 6 months prior to the screening;
- Subjects who have any prior history of substance abuse or treatment (including alcohol) ;
- Subjects who can't understand the purpose, extent and possible outcomes of the study because of mental disease;
- Adult subjects who are imprisoned or whose freedom are restricted because of administrative problem or legal issues;
- Subjects who can't comply with the protocol such as discontinue the follow-up and finish the study according to the protocol;
- Subjects who are involved in the study design and proceeding such as investigator, pharmacist, clinical research coordinator or other related personnel;
- Subjects who have any other unsuitable or adverse condition to be determined by the investigator;
- Subjects who have participated in a radiolabeled clinical trial prior to study medication;
- Subjects who have been exposed to significant radiation (e.g., x-ray investigation, CT investigation, more than one time radiation exposure in barium meal examination) or whose occupation requires exposure to radiation in the last 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase One Open-Label Single-Radiolabeled Dose Study to Investigate the Absorption, Metabolism, And Excretion Of [14C] Fruquintinib (HMPL-013) in Healthy Male Volunteers
This will be an open-label, single-center study to evaluate pharmacokinetics and safety of HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of HMPL-013 containing approximately 100 microcuries of [14C] HMPL-013. This study will investigate the absorption, drug biotransformation and mass balance of HMPL-013, seek to identify the compound's major metabolites and supply information for clinical application.
Read the detailed description
This study will be an open-label, mass balance study of fruquintinib administered orally at 5mg (100mCi). Subjects will be screened for eligibility up to 14 days prior to entry into the study. For study period, subjects will be admitted to the clinical research unit (CRU) on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for study period, subjects will receive a single oral dose of 5 mg fruquintinib in the fasted state. Subjects will remain at the CRU for at least 336 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.
- Conditions
- Healthy
- Being tested
- fruquintinib
- Keywords
- mass balance, 14C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fruquintinibDrug
Also called HMPL-013
fruquintinib suspension, 5mg ( 100mCi), oral, taken once, fast
| Study group | Role | What they receive |
|---|---|---|
| fruquintinib | Experimental | fruquintinib suspension, 5 mg （100 mCi）oral taken once Receives: Drug: fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity on blood, urine and faeces (radiocarbon) following oral suspension [14C]HMPL-013 dosing
Total radioactivity in blood to determine Cmax, Tmax, Half-life, AUC0-t, AUC0-∞ Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance)
Measured: Up to 14 days
Secondary outcomes (4)
Blood concentrations of HMPL-013 and its metabolites
Blood concentrations of HMPL-013 and its metabolites to determine Cmax, Tmax, Half-life, AUC0-t, AUC0-∞
Measured: Up to 14 days
Mass balance after a single oral dose of [14C] HMPL-013 as generated from recovery of total radioactivity excreted in urine and faeces.
Measured: Up to 14 days
Metabolite profililing and identification of metabolites in blood, urine and faeces
Measured: up to 14 days
Safety and tolerability parameters, including adverse events (AEs), vital signs, ECGs, and clinical laboratory assessments.
safety will assessed by physical exam, clinical laboratory evaluations and ECGs.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiguo Su, PHD, Study director, Hutchison Medipharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689752
- Sponsor's protocol ID
- 2015-013-00CH2
- Status last verified
- Feb 2020
- First submitted
- 3 Feb 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One Open-Label Single-Radiolabeled Dose Study to Investigate the Absorption, Metabolism, And Excretion Of [14C] Fruquintinib (HMPL-013) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02689752
- Acronym / sponsor ID
- 2015-013-00CH2
- Conditions
- Healthy
- Keywords
- mass balance, 14C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Feb 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.
This will be an open-label, single-center study to evaluate pharmacokinetics and safety of HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of HMPL-013 containing approximately 100 microcuries of [14C] HMPL-013. This study will investigate the absorption, drug biotransformation and mass balance of HMPL-013, seek to identify the compound's major metabolites and supply information for clinical application.
Detailed description
This study will be an open-label, mass balance study of fruquintinib administered orally at 5mg (100mCi). Subjects will be screened for eligibility up to 14 days prior to entry into the study. For study period, subjects will be admitted to the clinical research unit (CRU) on the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for study period, subjects will receive a single oral dose of 5 mg fruquintinib in the fasted state. Subjects will remain at the CRU for at least 336 hours after administration of study drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety monitoring.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fruquintinib | Experimental | Drug: fruquintinibfruquintinib suspension, 5 mg （100 mCi）oral taken once |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A Healthy Male Volunteer between 18 and 40 years of age inclusive;
- A Body Mass Index (BMI) within the range of 19 to 25 kg/m2 and a total body weight >50kg;
- Medically normal subjects with no significant abnormal findings at the screening vital signs, physical examination, electrocardiogram (ECG), and laboratory parameters as evaluated by the investigator;
- Fertile male subjects and their partners are willing to undergo contraception as follows: condom, contraceptive sponge, contraceptive gel, contraceptive diaphragm, intrauterine devices, hormonal contraceptives (oral or injectable), subepidermal contraceptive implant and other contraception methods during the study and until 1 year after taking the dose of investigational product,
- Subject must voluntarily consent to participate in this study, provide their written informed consent prior to start of any study- specific procedures and be willing to comply with all study procedures.
Key exclusion criteria (23 listed)
- Subjects who have a family history of coronary heart disease;
- Subjects who have a known history of bleeding such as gingival hemorrhage, epistaxis and hemorrhoid bleeding etc.;
- Subjects have hypertension (Systolic Pressure ≥140 mmHg or Diastolic Pressure ≥90 mmHg);
- Subjects who are taking, or have taken any drugs that affect metabolism or prescription medication during the screening or within 30 days prior to the screening; Subjects who are taking, or have taken any OTC, herbal remedies or Vitamin during the screening or within 14 days prior to the screening; Subjects who are taking, or have taken any plant extracts like Hypericum Perforatum L. which are not therapeutic but have health function and can affect the absorption and metabolism during the screening or within 3 days prior to the screening; Subjects who have participated in another clinical trial within 2 months prior to the screening;
- Subjects who are taking, or have taken any drugs which have toxicity to major organs during the screening or within 3 months prior to the screening;
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 |
|---|---|---|
| fruquintinibAlso: HMPL-013fruquintinib suspension, 5mg ( 100mCi), oral, taken once, fast | Drug | fruquintinib |
Primary outcome
Total radioactivity on blood, urine and faeces (radiocarbon) following oral suspension [14C]HMPL-013 dosing
Time frame: Up to 14 days
Total radioactivity in blood to determine Cmax, Tmax, Half-life, AUC0-t, AUC0-∞ Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance)
4 secondary outcomes
Blood concentrations of HMPL-013 and its metabolites
Time frame: Up to 14 days
Mass balance after a single oral dose of [14C] HMPL-013 as generated from recovery of total radioactivity excreted in urine and faeces.
Time frame: Up to 14 days
Metabolite profililing and identification of metabolites in blood, urine and faeces
Time frame: up to 14 days
Safety and tolerability parameters, including adverse events (AEs), vital signs, ECGs, and clinical laboratory assessments.
Time frame: Up to 14 days
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 13 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Weiguo Su, PHD study director
Hutchison Medipharma Limited
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 fruquintinib in people with Healthy, run by Hutchison Medipharma Limited 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 5 inclusion and 23 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 13 Feb 2020. 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?
Total radioactivity on blood, urine and faeces (radiocarbon) following oral suspension [14C]HMPL-013 dosing (time frame: Up to 14 days). 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 13 Feb 2020.