HealthyPhase 1NCT03977805
Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects
A Phase 1 study testing Hetrombopag Olamine in people with Healthy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a single-center, open-label, single-dose design. It is planning to enroll six Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be studied in these subjects after a single oral administration of a solution dose of [14C] Herombopag (5 mg, 100 uCi). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hetrombopag Olamine
- 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
- 25 May 2019to 13 Jun 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health male subjects, age between 18-45 years.
- BMI between 19 and 26 kg/m2 .
- Signed informed consent.
Who cannot join
- Abnormal results in physical examination、laboratory tests、X-ray、abdominal ultrasound、echocardiography have clinical significance.
- Abnormal platelet counts or platelet aggregation has clinical significance.
- Abnormal troponin examination has clinical significance.
- Abnormal ophthalmic examination has clinical significance.
- Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody is positive.
- Those who have a history of allergies to test drugs or similar drugs.
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- Those who have undergone surgery within 6 months prior to the trial .
- Those who took any drug within 14 days before the test (including Chinese herbal medicine).
- Any drug that inhibits or induces liver drug metabolism within 30 days before the test.
- Subjects who have participated in other clinical trial within the 3 months prior to study entry.
- One or more non-pharmacological contraceptive measures cannot be used during the trial or it is planned to have birth within one year.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a single-center, open-label, single-dose design. It is planning to enroll six Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be studied in these subjects after a single oral administration of a solution dose of [14C] Herombopag (5 mg, 100 uCi).
Read the detailed description
The metabolism and disposition of Herombopag, will be studied in six healthy men after a single oral administration of a solution dose of [14C]eltrombopag (5 mg,100 uCi).
The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma 、quantitatively analyze the the total radioactivity in the excreta、evaluate the predominant route of elimination and indentify the Metabolite profiles in plasma 、urine and faces.
- Conditions
- Healthy
- Being tested
- Hetrombopag Olamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag OlamineDrug
a single oral taking
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag Olamine | Experimental | Hetrombopag Olamine (5 mg, 100 uCi) Receives: Drug: Hetrombopag Olamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity pharmacokinetics in whole blood and plasma
plasma concentration of total radioactivity
Measured: From 1 hour before administration to 240 hours after administration
total radioactivity in the excreta
Excretion of radioactivity in human urine and feces
Measured: From 24 hour before administration to 336 hours after administration
the concentration of Hetrombopag in plasma
Area under the plasma concentration versus time curve (AUC)
Measured: From 1 hour before administration to 240 hours after administration
individual metabolite profiles in plasma 、urine and faces
Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse individual percentage of metabolites.
Measured: From 24 hour before administration to 336 hours after administration
mean metabolite profiles in plasma 、urine and faces
Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse mean percentage of metabolites.
Measured: From 24 hour before administration to 336 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start25 May 2019
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liyan Miao, PhD, Principal investigator, First Affiliated Hospital of Suzhou Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977805
- Sponsor's protocol ID
- HR-TPO-Ih
- Status last verified
- May 2020
- First submitted
- 5 May 2019
- Last updated
- 8 May 2020
- 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 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT03977805
- Acronym / sponsor ID
- HR-TPO-Ih
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2019 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 6 Jun 2019 (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 study is a single-center, open-label, single-dose design. It is planning to enroll six Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be studied in these subjects after a single oral administration of a solution dose of [14C] Herombopag (5 mg, 100 uCi).
Detailed description
The metabolism and disposition of Herombopag, will be studied in six healthy men after a single oral administration of a solution dose of [14C]eltrombopag (5 mg,100 uCi).
The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma 、quantitatively analyze the the total radioactivity in the excreta、evaluate the predominant route of elimination and indentify the Metabolite profiles in plasma 、urine and faces.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag Olamine | Experimental | Drug: Hetrombopag OlamineHetrombopag Olamine (5 mg, 100 uCi) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Health male subjects, age between 18-45 years.
- BMI between 19 and 26 kg/m2 .
- Signed informed consent.
Key exclusion criteria (11 listed)
- Abnormal results in physical examination、laboratory tests、X-ray、abdominal ultrasound、echocardiography have clinical significance.
- Abnormal platelet counts or platelet aggregation has clinical significance.
- Abnormal troponin examination has clinical significance.
- Abnormal ophthalmic examination has clinical significance.
- Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody is 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 |
|---|---|---|
| Hetrombopag Olaminea single oral taking | Drug | Hetrombopag Olamine |
Primary outcome
Total radioactivity pharmacokinetics in whole blood and plasma
Time frame: From 1 hour before administration to 240 hours after administration
plasma concentration of total radioactivity
total radioactivity in the excreta
Time frame: From 24 hour before administration to 336 hours after administration
Excretion of radioactivity in human urine and feces
the concentration of Hetrombopag in plasma
Time frame: From 1 hour before administration to 240 hours after administration
Area under the plasma concentration versus time curve (AUC)
individual metabolite profiles in plasma 、urine and faces
Time frame: From 24 hour before administration to 336 hours after administration
Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse individual percentage of metabolites.
mean metabolite profiles in plasma 、urine and faces
Time frame: From 24 hour before administration to 336 hours after administration
Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse mean percentage of metabolites.
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 8 May 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.
Liyan Miao, PhD principal investigator
First Affiliated Hospital of Suzhou Medical College
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 Hetrombopag Olamine in people with Healthy, 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 11 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 8 May 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 pharmacokinetics in whole blood and plasma (time frame: From 1 hour before administration to 240 hours after administration). 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 8 May 2020.