HealthyPhase 1NCT01830660
A Phase I Study of Hetrombopag Olamine in Healthy Adult Volunteers
A Phase 1 study testing Hetrombopag Olamine Tablets in people with Healthy, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of increasing platelet count in animal and human. This study is designed in dose escalation fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine. 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 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Jun 2013
- 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
- Subject must be adequately informed of the nature and risks of the study, able to understand the risks associated with the study, and are willing to provide written informed consent prior to screening.
- Must be a healthy male between the ages of 18 to 45 years, inclusive.
- Must have a BMI between 19 to 28 kg/m2, inclusive and a total body weight ≥50 kg.
- Platelet counts must be within the normal range.
- Subjects must be free of any clinically significant disease based on medical history and physical examination.
- Clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) must be within the normal limits or clinically acceptable.
- Must be nonsmokers, defined as not having smoked tobacco or used chewing tobacco or nicotine.
- Subjects of reproductive potential with partners who are women of childbearing potential, will be instructed to, and must be willing to practice a highly effective method of birth control for the duration of the study and continuing 6 months after discontinuing treatment with the investigational product.
Who cannot join
- History of hypersensitivity to hetrombopag olamine or its components.
- History or presence of significant cardiovascular deficient, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of deep vein thrombosis, or any other thromboembolic event.
- History or presence of conditions that may place the subject at increased risk as determined by the investigator.
- History of thrombocytopenia or bleeding due to abnormal platelet number or function.
- History of platelet clumping that prevents reliable measurement of platelet counts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Placebo-controlled, Ascending Single And Multiple Oral Dose Study To Investigate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Hetrombopag Olamine (SHR8735 Olamine) In Healthy Subjects
Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of increasing platelet count in animal and human. This study is designed in dose escalation fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.
Read the detailed description
- To evaluate safety and tolerability of Hetrombopag Olamine.
- To investigate pharmacokinetics of Hetrombopag Olamine Under fasting conditions.
- To obtain pharmacodynamics information of Hetrombopag Olamine on platelet count elevation in healthy volunteers.
- To determine preliminary regimen for phase II study.
- Conditions
- Healthy
- Being tested
- Hetrombopag Olamine Tablets, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag Olamine TabletsDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| hetrombopag | Experimental | hetrombopag either at 2.5,5,10,20,30 or 40mg, p.o. once daily Receives: Drug: Hetrombopag Olamine Tablets |
| placebo | Placebo comparator | Subjects will be randomized (5:1 eltrombopag : placebo) to receive either eltrombopag or placebo. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet count above baseline(%)on Day1,3,5,8,10,12,15,17,19,22,25,28 after dosing
Measured: up to 4 weeks
Composite pharmacokinetic (PK) parameters of eltrombopag following a single dose of eltrombopag
Measured: For 5 days
Secondary outcomes (3)
Adverse events
Measured: up to 4 weeks
Change in vital signs
Measured: up to 4 weeks
Change in clinical laboratory parameters
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionJun 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maozhi Liang, Dr, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830660
- Sponsor's protocol ID
- SHR-TPOP1
- Status last verified
- Apr 2013
- First submitted
- 25 Dec 2012
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Placebo-controlled, Ascending Single And Multiple Oral Dose Study To Investigate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Hetrombopag Olamine (SHR8735 Olamine) In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01830660
- Acronym / sponsor ID
- SHR-TPOP1
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Apr 2013 (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.
Hetrombopag Olamine made by Jiangsu Hengrui Medicine co Ltd. has shown an effect of increasing platelet count in animal and human. This study is designed in dose escalation fashion to evaluate safety, pharmacokinetics and efficacy of Hetrombopag Olamine.
Detailed description
- To evaluate safety and tolerability of Hetrombopag Olamine.
- To investigate pharmacokinetics of Hetrombopag Olamine Under fasting conditions.
- To obtain pharmacodynamics information of Hetrombopag Olamine on platelet count elevation in healthy volunteers.
- To determine preliminary regimen for phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hetrombopag | Experimental | Drug: Hetrombopag Olamine Tabletshetrombopag either at 2.5,5,10,20,30 or 40mg, p.o. once daily |
| placebo | Placebo comparator | Drug: placeboSubjects will be randomized (5:1 eltrombopag : placebo) to receive either eltrombopag or placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject must be adequately informed of the nature and risks of the study, able to understand the risks associated with the study, and are willing to provide written informed consent prior to screening.
- Must be a healthy male between the ages of 18 to 45 years, inclusive.
- Must have a BMI between 19 to 28 kg/m2, inclusive and a total body weight ≥50 kg.
- Platelet counts must be within the normal range.
- Subjects must be free of any clinically significant disease based on medical history and physical examination.
Key exclusion criteria (6 listed)
- History of hypersensitivity to hetrombopag olamine or its components.
- History or presence of significant cardiovascular deficient, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of deep vein thrombosis, or any other thromboembolic event.
- History or presence of conditions that may place the subject at increased risk as determined by the investigator.
- History of thrombocytopenia or bleeding due to abnormal platelet number or function.
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 Olamine Tablets | Drug | hetrombopag |
| placebo | Drug | placebo |
Primary outcome
Change in platelet count above baseline(%)on Day1,3,5,8,10,12,15,17,19,22,25,28 after dosing
Time frame: up to 4 weeks
Composite pharmacokinetic (PK) parameters of eltrombopag following a single dose of eltrombopag
Time frame: For 5 days
3 secondary outcomes
Adverse events
Time frame: up to 4 weeks
Change in vital signs
Time frame: up to 4 weeks
Change in clinical laboratory parameters
Time frame: up to 4 weeks
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 6 Apr 2015.
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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.
Maozhi Liang, Dr principal investigator
West China 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 Hetrombopag Olamine Tablets 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 8 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 6 Apr 2015. 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. Some participants in this study may receive a placebo. 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?
Change in platelet count above baseline(%)on Day1,3,5,8,10,12,15,17,19,22,25,28 after dosing (time frame: up to 4 weeks). The study lists 2 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 6 Apr 2015.