HealthyEarly Phase 1NCT03627520
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib
A Early Phase 1 study testing [14C]Sulfatinib in people with Healthy, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of [14C]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]Sulfatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2018to 1 Jul 2018
- Phase
- Early 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written Informed Consent Form (ICF)
- Age of 18-50 (inclusive)；
- Body weight over 50 kg and body mass index (BMI) between 19-26 kg / m2 (inclusive)；
Who cannot join
- Laboratory tests (blood tests, blood biochemical tests [fasting], coagulation tests, thyroid function tests, urinalysis, fecal occult blood) judged as clinically significant abnormal by investigators；
- Clinically significant abnormal ECG at screening and before screening；
- Hepatitis B surface antigen (HBsAg), e antigen (HBeAg) or hepatitis C antibody (HCV Ab) test positive；
- Human immunodeficiency virus (HIV) antibody positive；
- Treponema pallidum antibody positive.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 300 mg /100 μCi [14C] Sulfatinib in Chinese Adult Male Healthy Volunteers
This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of [14C]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.
Read the detailed description
In order to determine the optimal time point for sample collection, this study will be divided into two stages: the first stage, two volunteers will be enrolled, the volunteers should stop collecting the corresponding samples by the investigators based on radioactive test results, safety results combined with the actual comprehensive situation. And in the second stage sample collection time for another four volunteers will be determined and adjusted according to the results of the first stage.
- Conditions
- Healthy
- Being tested
- [14C]Sulfatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]SulfatinibDrug
Also called 300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib
300 mg Sulfatinib with 100 µCi [14C]
| Study group | Role | What they receive |
|---|---|---|
| [14C]Sulfatinib | Other | This is a single center and single dose in 6 volunteers. Subject would take a suspension containing 300 mg of Sulfatinib (containing about 100 μCi of radioactivity) within 1 hour after standard breakfast. Receives: Drug: [14C]Sulfatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of total radioactivity of [14C] Sulfatinib
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
Measured: Measured from the 0 hour to 216 hours
Secondary outcomes (5)
To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib
Maximum observed concentration, occurring at Tmax.
Measured: Measured from the 0 hour to 216 hours
To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib
The time at which maximum plasma concentration (Cmax) is observed.
Measured: Measured from the 0 hour to 216 hours
To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib
The time at which Half-life (t1/2) is observed.
Measured: Measured from the 0 hour to 216 hours
To obtain mass balance data after a single oral dose of [14C] Sulfatinib
Quantitative analysis of total radioactivity in the excretion of Sulfatinib
Measured: Measured on the Day1 to Day15
To observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.
Adverse Event (AE) monitoring of [14C] Sulfatinib
Measured: Measured from the date signed ICF to within 15 days after the single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start2 Apr 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is single centre, open label, single dose study
- 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
- Ke LI, PhD, Study director, Hutchison Medipharma Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627520
- Sponsor's protocol ID
- 2017-012-00CH1
- Status last verified
- Jan 2019
- First submitted
- 13 Mar 2018
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 300 mg /100 μCi [14C] Sulfatinib in Chinese Adult Male Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03627520
- Acronym / sponsor ID
- 2017-012-00CH1
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 13 Aug 2018 (actual)
- 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 is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of [14C]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.
Detailed description
In order to determine the optimal time point for sample collection, this study will be divided into two stages: the first stage, two volunteers will be enrolled, the volunteers should stop collecting the corresponding samples by the investigators based on radioactive test results, safety results combined with the actual comprehensive situation. And in the second stage sample collection time for another four volunteers will be determined and adjusted according to the results of the first stage.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is single centre, open label, single dose study
| Arm | Type | Receives |
|---|---|---|
| [14C]Sulfatinib | Other | Drug: [14C]SulfatinibThis is a single center and single dose in 6 volunteers. Subject would take a suspension containing 300 mg of Sulfatinib (containing about 100 μCi of radioactivity) within 1 hour after standard breakfast. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of written Informed Consent Form (ICF)
- Age of 18-50 (inclusive)；
- Body weight over 50 kg and body mass index (BMI) between 19-26 kg / m2 (inclusive)；
Key exclusion criteria (5 listed)
- Laboratory tests (blood tests, blood biochemical tests [fasting], coagulation tests, thyroid function tests, urinalysis, fecal occult blood) judged as clinically significant abnormal by investigators；
- Clinically significant abnormal ECG at screening and before screening；
- Hepatitis B surface antigen (HBsAg), e antigen (HBeAg) or hepatitis C antibody (HCV Ab) test positive；
- Human immunodeficiency virus (HIV) antibody positive；
- Treponema pallidum antibody positive.
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 |
|---|---|---|
| [14C]SulfatinibAlso: 300 mg /100 μCi [14C] Sulfatinib, Sulfatinib, HMPL-012, Surufatinib300 mg Sulfatinib with 100 µCi [14C] | Drug | [14C]Sulfatinib |
Primary outcome
To investigate the area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of total radioactivity of [14C] Sulfatinib
Time frame: Measured from the 0 hour to 216 hours
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
5 secondary outcomes
To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib
Time frame: Measured from the 0 hour to 216 hours
To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib
Time frame: Measured from the 0 hour to 216 hours
To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib
Time frame: Measured from the 0 hour to 216 hours
To obtain mass balance data after a single oral dose of [14C] Sulfatinib
Time frame: Measured on the Day1 to Day15
To observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.
Time frame: Measured from the date signed ICF to within 15 days after the single dose
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 23 Apr 2019.
- 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.
Ke LI, PhD study director
Hutchison Medipharma Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [14C]Sulfatinib 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 3 inclusion and 5 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 23 Apr 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
To investigate the area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of total radioactivity of [14C] Sulfatinib (time frame: Measured from the 0 hour to 216 hours). 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 23 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.