Healthy SubjectsPhase 1NCT05088343
Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects
A Phase 1 study testing Rosuvastatin and Hetrombopag in people with Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Rosuvastatin and Hetrombopag
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2020to 16 Jan 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 55 (including 18 and 55) at the date of signing the informed consent;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26).
Who cannot join
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
- History of deep vein thrombosis, or any other thromboembolic event;
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
- Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Chinese Adult Subjects.
Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.
Read the detailed description
The primary objective of the study is to evaluate the effect of hetrombopag on pharmacokinetics of healthy Chinese adult subjects after oral administration of rosuvastatin calcium tablets. The secondary objective of the study is to evaluate the safety of rosuvastatin alone and when co-administered with hetrombopag.
- Conditions
- Healthy Subjects
- Being tested
- Rosuvastatin, Hetrombopag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Single oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11.
HetrombopagDrug
7.5 mg hetrombopag was administered on Day 6 to Day 11.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | rosuvastatin alone and then in combination with hetrombopag Receives: Drug: Rosuvastatin; Drug: Hetrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax)
Measured: 0-72 hours post dose
Area Under the plasma concentration vs time curve (AUC0-72)
Measured: 0-72 hours post dose
Area under the blood concentration vs time curve (AUC0-inf)
Measured: 0-infinity
Secondary outcomes (2)
Other pharmacokinetics parameters of rosuvastatin
Tmax
Measured: 0-72 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability
Measured: up to Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start7 Sep 2020
- Primary completion16 Jan 2021
- Study completion16 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- rosuvastatin alone and then in combination with hetrombopag
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xueying Ding, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088343
- Sponsor's protocol ID
- SHR8735-110
- Status last verified
- Feb 2021
- First submitted
- 25 Jan 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Chinese Adult Subjects.
- ClinicalTrials.gov ID
- NCT05088343
- Acronym / sponsor ID
- SHR8735-110
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 16 Jan 2021 (actual)
- Study completion
- 16 Jan 2021 (actual)
- First posted
- 21 Oct 2021 (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.
Effect of hetrombopag on the pharmacokinetics of rosuvastatin in healthy subjects.
Detailed description
The primary objective of the study is to evaluate the effect of hetrombopag on pharmacokinetics of healthy Chinese adult subjects after oral administration of rosuvastatin calcium tablets. The secondary objective of the study is to evaluate the safety of rosuvastatin alone and when co-administered with hetrombopag.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- rosuvastatin alone and then in combination with hetrombopag
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Rosuvastatin, Drug: Hetrombopagrosuvastatin alone and then in combination with hetrombopag |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
- Ability to complete the study as required by the protocol;
- Healthy male or female subjects aged 18 to 55 (including 18 and 55) at the date of signing the informed consent;
- Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26).
Key exclusion criteria (6 listed)
- Allergic constitution;
- History of drug use, or drug abuse screening positive;
- Alcoholic or often drinkers;
- History of deep vein thrombosis, or any other thromboembolic event;
- A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.
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 |
|---|---|---|
| RosuvastatinSingle oral dose of rosuvastatin on Day 1 or co-administered with hetrombopag on Day 11. | Drug | Treatment |
| Hetrombopag7.5 mg hetrombopag was administered on Day 6 to Day 11. | Drug | Treatment |
Primary outcome
Peak plasma concentration (Cmax)
Time frame: 0-72 hours post dose
Area Under the plasma concentration vs time curve (AUC0-72)
Time frame: 0-72 hours post dose
Area under the blood concentration vs time curve (AUC0-inf)
Time frame: 0-infinity
2 secondary outcomes
Other pharmacokinetics parameters of rosuvastatin
Time frame: 0-72 hours post dose
The number of volunteers with adverse events as a measure of safety and tolerability
Time frame: up to Day 20
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 21 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Xueying Ding principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 Rosuvastatin and Hetrombopag in people with Healthy Subjects, 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 4 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 21 Oct 2021. 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?
Peak plasma concentration (Cmax) (time frame: 0-72 hours post dose). 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?
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 21 Oct 2021.