Immune ThrombocytopeniaPhase 1NCT03603132
A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics
A Phase 1 study testing Hetrombopag Olamine in people with Immune Thrombocytopenia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Hetrombopag Olamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2018to 17 Aug 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
- Signed informed consent.
Who cannot join
- Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
- Having deep vein thrombosis or other thrombotic diseases.
- Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
- Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec)
- Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.
- Those who have a history of allergies to drugs , food or test drugs or similar drugs;
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- Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study
- 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 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 six months.
Trial locations and contacts
1 site in 1 country.
China1 site
The third xiangya hospital Hospital,of central south university
Changsha, Hunan, 410013
About this study
Official title: Effects of Different Dosing and Feeding Intervals on the Pharmacokinetic Parameters of Herombopag Olamine Tablets
This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.
- Conditions
- Immune Thrombocytopenia
- Being tested
- Hetrombopag Olamine
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag OlamineDrug
7.5mg in each cycle
| Study group | Role | What they receive |
|---|---|---|
| Hetrombopag Olamine A | Active comparator | health subjects received 7.5 mg Hetrombopag Olamine while fasting. Receives: Drug: Hetrombopag Olamine |
| Hetrombopag Olamine B | Active comparator | health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine Receives: Drug: Hetrombopag Olamine |
| Hetrombopag Olamine C | Active comparator | health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine Receives: Drug: Hetrombopag Olamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: from baseline up to Day 26
Secondary outcomes (2)
Peak Plasma Concentration (Cmax)
Measured: pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group
Area under the plasma concentration versus time curve (AUC)
Measured: pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start14 Jul 2018
- Primary completion17 Aug 2018
- Study completion17 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603132
- Sponsor's protocol ID
- HR-TPO-Ig
- Status last verified
- May 2019
- First submitted
- 18 Jun 2018
- Last updated
- 7 May 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 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Dosing and Feeding Intervals on the Pharmacokinetic Parameters of Herombopag Olamine Tablets
- ClinicalTrials.gov ID
- NCT03603132
- Acronym / sponsor ID
- HR-TPO-Ig
- Conditions
- Immune Thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jul 2018 (actual)
- Primary completion
- 17 Aug 2018 (actual)
- Study completion
- 17 Aug 2018 (actual)
- First posted
- 27 Jul 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 study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hetrombopag Olamine A | Active comparator | Drug: Hetrombopag Olaminehealth subjects received 7.5 mg Hetrombopag Olamine while fasting. |
| Hetrombopag Olamine B | Active comparator | Drug: Hetrombopag Olaminehealth subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine |
| Hetrombopag Olamine C | Active comparator | Drug: Hetrombopag Olaminehealth subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
- Signed informed consent.
Key exclusion criteria (11 listed)
- Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
- Having deep vein thrombosis or other thrombotic diseases.
- Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
- Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec)
- Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV 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 |
|---|---|---|
| Hetrombopag Olamine7.5mg in each cycle | Drug | Hetrombopag Olamine A, Hetrombopag Olamine B, Hetrombopag Olamine C |
Primary outcome
Adverse events
Time frame: from baseline up to Day 26
2 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group
Area under the plasma concentration versus time curve (AUC)
Time frame: pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group
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 7 May 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Immune Thrombocytopenia, 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 7 May 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?
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?
Adverse events (time frame: from baseline up to Day 26). 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 7 May 2019.