HealthyPhase 1NCT02409394
Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy 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 open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects. 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
- 12 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Apr 2014
- 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
- Healthy.
- Weight≥50 kg，19≤BMI≤28 kg/m2.
- Platelet count is within normal range
Who cannot join
- History of clinically significant illness.
- History of alcohol or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.
- Conditions
- Healthy
- Being tested
- Hetrombopag Olamine
- Keywords
- Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hetrombopag OlamineDrug
| Study group | Role | What they receive |
|---|---|---|
| hetrombopag 7.5mg fasted to fed | Experimental | Hetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11. Receives: Drug: Hetrombopag Olamine |
| hetrombopag 7.5mg fed to fasted | Experimental | Hetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11. Receives: Drug: Hetrombopag Olamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum plasma concentration (Cmax) of hetrombopag
Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
Measured: 0h-120h
The area under the plasma concentration-time curve (AUC) of hetrombopag
AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
Measured: 0h-120h
The accumulative excretion rate of hetrombopag and its metabolites in urine and feces
Measured: 0h-120h
Secondary outcomes (2)
The change of platelet count
Measured: On day 2, 4, 6, 8,12, 14 and 16
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02409394
- Sponsor's protocol ID
- TPOP1c
- Status last verified
- Apr 2015
- First submitted
- 1 Apr 2015
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang Z, Chen X, Li A, Chen L, Wang Y, Zheng L. Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers. Clin Ther. 2020 Dec;42(12):2280-2288. doi: 10.1016/j.clinthera.2020.10.002. Epub 2020 Oct 24.
PubMed 33109386
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
- Effect of a High-fat Meal on the Pharmacokinetics of Hetrombopag and Mass Balance Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02409394
- Acronym / sponsor ID
- TPOP1c
- Conditions
- Healthy
- Keywords
- Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Apr 2015 (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.
This open-label, randomized, two-period, two-treatment (single doses of 7.5 mg hetrombopag fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of hetrombopag and mass balance study in 12 healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hetrombopag 7.5mg fasted to fed | Experimental | Drug: Hetrombopag OlamineHetrombopag tablet, fasting conditions on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet with high fat, high calorie breakfast on day 11. |
| hetrombopag 7.5mg fed to fasted | Experimental | Drug: Hetrombopag OlamineHetrombopag tablet with high fat, high calorie breakfast on day 1; 9 days wash-out; Than subjects will be crossover to have hetrombopag tablet, under fasting condition on day 11. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy.
- Weight≥50 kg，19≤BMI≤28 kg/m2.
- Platelet count is within normal range
Key exclusion criteria (2 listed)
- History of clinically significant illness.
- History of alcohol or drug abuse.
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 | Drug | hetrombopag 7.5mg fasted to fed, hetrombopag 7.5mg fed to fasted |
Primary outcome
The maximum plasma concentration (Cmax) of hetrombopag
Time frame: 0h-120h
Cmax (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
The area under the plasma concentration-time curve (AUC) of hetrombopag
Time frame: 0h-120h
AUC (a measure of the body's exposure to hetrombopag) will be compared under fating state and fasted state
The accumulative excretion rate of hetrombopag and its metabolites in urine and feces
Time frame: 0h-120h
2 secondary outcomes
The change of platelet count
Time frame: On day 2, 4, 6, 8,12, 14 and 16
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 16
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.
- Derived from this study: PubMed 33109386Wang Z, Chen X, Li A, Chen L, Wang Y, Zheng L. Effect of Food on the Pharmacokinetic and Pharmacodynamic Profiles of Hetrombopag in Healthy Volunteers. Clin Ther. 2020 Dec;42(12):2280-2288. doi: 10.1016/j.clinthera.2020.10.002. Epub 2020 Oct 24.
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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 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 2 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. 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 maximum plasma concentration (Cmax) of hetrombopag (time frame: 0h-120h). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409394, which also lists 1 linked publication.
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.