Relative BioavailabilityPhase 1CRC-C1721NCT03483259
To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers
A Phase 1 study testing Sulfatinib T capsule and Sulfatinib R capsule in people with Relative Bioavailability, run by Hutchison Medipharma Limited at 1 site in China.
Trial summary
This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Relative Bioavailability
- What is being tested?
- Sulfatinib T capsule and Sulfatinib R capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2018to 18 May 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol；
- Age of 18-40 (inclusive), male healthy volunteers；
- Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
- Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
- Men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this study；
Who cannot join
- Any clinically significant disease or condition includes but not limited to metabolism/endocrine, liver, kidney, blood, lung, immune, cardiovascular, gastrointestinal, genito-urinary, nervous, or mental illness that judged by the investigator within 3 months before screening;
- Previous gastrointestinal surgery, kidney surgery, cholecystectomy and surgery history may affect the absorption or excretion of drugs;
- Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
- Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) test positive, HIV or treponema pallidum antibodies test positive;
- Any drugs that may change the liver and kidney clearance;
- Take any prescription drug (including Chinese herbal medicine) within 14 days before dosing; or use any over-the-counter drugs (including but not limited to vitamins, prophylaxis, plant health products) within 7 days before dosing;
- Clinical trials of other medications before screening, less than a 5-fold half-life or 28 days from the time of the last other study drug, whichever is longer;
- Any history of clinically serious disease or condition that the investigator believes may affect the outcome of this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui District Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers
This is a single-center, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.
Read the detailed description
27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.
- Conditions
- Relative Bioavailability
- Being tested
- Sulfatinib T capsule, Sulfatinib R capsule
- Keywords
- Pharmacokinetics, Relative bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfatinib T capsuleDrug
Also called HMPL-012, Surufatinib
Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
Sulfatinib R capsuleDrug
Also called HMPL-012, Surufatinib
Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Arm A-Sulfatinib T capsule | Experimental | The subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. Receives: Drug: Sulfatinib T capsule |
| Arm B-Sulfatinib R capsule | Experimental | The subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd. Receives: Drug: Sulfatinib R capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
Measured: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Maximum observed plasma concentration (Cmax) of Sulfatinib
Maximum observed concentration, occurring at Tmax.
Measured: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
The time to Cmax (peak time, Tmax) of Sulfatinib
The time at which maximum plasma concentration (Cmax) is observed.
Measured: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Half-life (t1/2) of Sulfatinib
The time required for the concentration of the drug to reach half of its original value.
Measured: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Relative Bioavailability
This term represents the relationship between the bioavailability of a substance in two different media.
Measured: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Secondary outcomes (1)
Adverse Event (AE) monitoring of Sulfatinib
AE monitoring will be assessed by incidence of AEs, AE grading, serious AEs, as well as laboratory determinations and vital sign parameters.
Measured: Measured from the date signed ICF to within 14 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start2 Apr 2018
- Primary completion12 May 2018
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative BioavailabilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects who did not meet the exclusion criteria were randomly assigned to one of the three groups: group A, B, and C (administration TRR, RTR and RRT, 9 subjects in each group, where T is the test formulation and R is the reference formulation) .
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hutchison Medipharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liu Yanmei, Master, Principal investigator, Shanghai Xuhui District Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483259
- Sponsor's protocol ID
- 2016-012-00CH2
- Acronym
- CRC-C1721
- Status last verified
- Nov 2018
- First submitted
- 8 Mar 2018
- Last updated
- 13 Nov 2018
- 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 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Pharmacokinetics and Relative Bioavailability of Sulfatinib Capsules in Two Different Manufacturers in Chinese Adult Male Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03483259
- Acronym / sponsor ID
- CRC-C1721 / 2016-012-00CH2
- Conditions
- Relative Bioavailability
- Keywords
- Pharmacokinetics, Relative bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hutchison Medipharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 12 May 2018 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 30 Mar 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, randomized, open, single-dose, three-cycle cross-design study, which will be only enrolled Chinese male healthy volunteers.
Detailed description
27-30 Chinese male healthy volunteers will be enrolled to assess the pharmacokinetic profile and relative bioavailability of 300 mg (50 mg x 6) Sulfatinib capsules of single dose orally in two different manufacturers after breakfast. All subjects are required to collect PK blood samples before and after administration at the following time points: within 1 hour before administration, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48, 72, 96 hours after administration (16 times point), each collection of venous blood is 2mL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible subjects who did not meet the exclusion criteria were randomly assigned to one of the three groups: group A, B, and C (administration TRR, RTR and RRT, 9 subjects in each group, where T is the test formulation and R is the reference formulation) .
| Arm | Type | Receives |
|---|---|---|
| Arm A-Sulfatinib T capsule | Experimental | Drug: Sulfatinib T capsuleThe subjects in this arm will receive sulfatinib T capsules from Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. |
| Arm B-Sulfatinib R capsule | Experimental | Drug: Sulfatinib R capsuleThe subjects in this arm will receive sulfatinib R capsules from Beijing Yiling Bioengineering Technology Co., Ltd. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must be voluntary and sign an informed consent form and agree to comply with the requirements of the protocol；
- Age of 18-40 (inclusive), male healthy volunteers；
- Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
- Medical history, physical examination, 12-lead ECG and laboratory tests at screening judged as normal or abnormal but not clinically significant by investigators;
- Men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this study；
Key exclusion criteria (8 listed)
- Any clinically significant disease or condition includes but not limited to metabolism/endocrine, liver, kidney, blood, lung, immune, cardiovascular, gastrointestinal, genito-urinary, nervous, or mental illness that judged by the investigator within 3 months before screening;
- Previous gastrointestinal surgery, kidney surgery, cholecystectomy and surgery history may affect the absorption or excretion of drugs;
- Hypertension: systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg;
- Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) test positive, HIV or treponema pallidum antibodies test positive;
- Any drugs that may change the liver and kidney clearance;
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 |
|---|---|---|
| Sulfatinib T capsuleAlso: HMPL-012, SurufatinibSulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production. | Drug | Arm A-Sulfatinib T capsule |
| Sulfatinib R capsuleAlso: HMPL-012, SurufatinibSulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd. | Drug | Arm B-Sulfatinib R capsule |
Primary outcome
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
Maximum observed plasma concentration (Cmax) of Sulfatinib
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
Maximum observed concentration, occurring at Tmax.
The time to Cmax (peak time, Tmax) of Sulfatinib
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
The time at which maximum plasma concentration (Cmax) is observed.
Half-life (t1/2) of Sulfatinib
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
The time required for the concentration of the drug to reach half of its original value.
Relative Bioavailability
Time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5
This term represents the relationship between the bioavailability of a substance in two different media.
1 secondary outcome
Adverse Event (AE) monitoring of Sulfatinib
Time frame: Measured from the date signed ICF to within 14 days after the last 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 13 Nov 2018.
- 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.
Liu Yanmei, Master principal investigator
Shanghai Xuhui District Central Hospital
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 Sulfatinib T capsule and Sulfatinib R capsule in people with Relative Bioavailability, 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 8 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 Nov 2018. 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?
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of Sulfatinib (time frame: Measured on the Cycle1 Day1 to Day5, Cycle2 Day1 to Day5, Cycle3 Day1 to Day5). The study lists 5 primary outcomes in all. 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 Nov 2018.