Primary Mild and Moderate HypertensionPhase 1/2NCT05593562
Study on Human Mass Balance of SPH3127 Tablets
A Phase 1/2 study testing SPH3127 in people with Primary Mild and Moderate Hypertension, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of [14C] SPH3127, and determine the cumulative excretion rate and main excretion routes of radioactive substances; to investigate the partition in whole blood and plasma and the pharmacokinetics of total… 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
- Primary Mild and Moderate Hypertension
- What is being tested?
- SPH3127
- 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
- 16 Oct 2022to 24 Oct 2022
- Phase
- Phase 1/2
- 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 adult male;
- Age: 18-45 years (inclusive);
- Body weight: the body weight of the subject is ≥ 50 kg, and the body mass index (BMI) is between 19 and 26 kg/m2 (inclusive);
- Subject who fully understands the objective, requirements, content, process and possible adverse reactions of this trial, volunteers for the trial, is able to complete the trial according to the trial requirements and comply with study instructions, and the process of obtaining informed consent conforms to GCP;
- Subject who can communicate well with the investigator and complete the trial according to the protocol.
Who cannot join
- Those with clinically significant abnormalities in physical examination, vital signs, laboratory tests, thyroid function, 12-lead ECG, chest CT, abdominal ultrasound and other examinations;
- Those positive for combined detection of hepatitis B surface antigen or e antigen, hepatitis C virus antibody IgG, human immunodeficiency virus antigen/antibody and Treponema pallidum antibody;
- Screening for SARS-COV-2 infection: those with clinically significant abnormalities in C-reactive protein or positive for SARS-COV-2 RNA;
- Those who have used any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days prior to screening;
- Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements within 14 days prior to screening;
- Those who have a history of any clinical serious disease or any disease or condition that the investigator thinks may affect the trial results, including but not limited to the medical history of circulatory system, respiratory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic disorders;
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- Those with a personal history or family history of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmias, torsades de pointes, ventricular tachycardia, atrioventricular block, prolonged QT syndrome;
- Those who have undergone major surgery or have incomplete healing of surgical incision within 6 months prior to screening; major surgery includes, but is not limited to, any surgery with significant bleeding risk, prolonged general anesthesia, or open biopsy or significant traumatic injury;
- Those with allergic constitution, such as a known history of allergy to two or more substances; or those who, at the investigator's discretion, may be allergic to the investigational drug or its excipients;
- Those with perianal disease, irritable bowel syndrome, inflammatory bowel disease with regular/ongoing hematochezia;
- Those with habitual constipation or diarrhea;
- Those who drink excessively or drink frequently within 6 months prior to screening, that is, drinking more than 14 units of alcohol every week and unable to quit during the trial; or the alcohol breath test result is > 0 mg/dL during screening period;
- Those who smoke more than 5 cigarettes a day or habitually used nicotine-containing products within three months prior to screening, and are unable to quit during the trial;
- Those who have a history of drug abuse within 3 months prior to screening or have a positive urine test for illegal drugs during screening;
- Those who habitually drink grapefruit juice or excessive tea, coffee and/or caffeinated drinks, and are unable to quit during the trial;
- Those who need to be exposed to radioactive conditions for a long time; or those who have had significant radiation exposure or participated in radiopharmaceutical labeling test within 1 year prior to screening;
- Those who have a history of fear of needles or blood fainting, and who have difficulty in blood collection or are unable to tolerate venous puncture for blood collection;
- Those who have participated in any other clinical trial within 3 months prior to screening;
- Those who have been vaccinated within one month prior to screening or who plan to be vaccinated during the trial;
- Those who have fertility or sperm donation plans during the trial and within one year after the completion of the trial, or do not agree to take strict contraceptive measures with their female partners throughout the trial and for up to one year after the completion of the trial;
- Those who have lost blood or donated blood up to 200 mL within 3 months or have received blood transfusion within 1 month prior to screening;
- Subjects who are considered by the investigator as having any factors unsuitable for this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Evaluate Absorption, Metabolism and Excretion of [14C]SPH3127 in Healthy Chinese Adult Male Subjects (Human Mass Balance and Biotransformation Study of [14C]SPH3127)
To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of [14C] SPH3127, and determine the cumulative excretion rate and main excretion routes of radioactive substances; to investigate the partition in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C]SPH3127 in healthy male subjects; to identify the main metabolites in healthy male subjects after an oral administration of [14C] SPH3127, determine the main biotransformation pathways and main metabolites, quantitatively analyze the concentration of SPH3127 and main metabolites in plasma by validated LC-MS/MS method, and establish the pharmacokinetic parameters of SPH3127 and its main metabolites in plasma.
- Conditions
- Primary Mild and Moderate Hypertension
- Being tested
- SPH3127
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH3127Drug
Oral 100 mg [14 c] SPH3127 mixed suspension
| Study group | Role | What they receive |
|---|---|---|
| SPH3127 | Experimental | Oral 100 mg [14 c] SPH3127 mixed suspension Receives: Drug: SPH3127 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion rate of total radioactive substances in excreta
Cumulative excretion rate of total radioactive substances in excreta(urine and faeces).
Measured: 240 hours
The concentration of SPH3127 in plasma
The concentration of SPH3127 in plasma was determined by liquid chromatography tandem mass spectrometry (LC-MS/MS).
Measured: Sampling performed at predose, and 10 minute,20 minute,0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24,48,72,96,120,144and 168 hours post-dose.
The total radioactivity in the collected plasma samples
The total radioactivity in the collected plasma samples was measured directly by liquid scintillation counter.
Measured: up to 168 hours
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, correlation with study drug
Measured: Predose and 240 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start16 Oct 2022
- Primary completion24 Oct 2022
- Study completion24 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Mild and Moderate HypertensionStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593562
- Sponsor's protocol ID
- SPH3127-105
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate Absorption, Metabolism and Excretion of [14C]SPH3127 in Healthy Chinese Adult Male Subjects (Human Mass Balance and Biotransformation Study of [14C]SPH3127)
- ClinicalTrials.gov ID
- NCT05593562
- Acronym / sponsor ID
- SPH3127-105
- Conditions
- Primary Mild and Moderate Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 24 Oct 2022 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 25 Oct 2022 (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.
To quantitatively analyze the total radioactivity in the excreta of healthy male subjects after oral administration of [14C] SPH3127, and determine the cumulative excretion rate and main excretion routes of radioactive substances; to investigate the partition in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C]SPH3127 in healthy male subjects; to identify the main metabolites in healthy male subjects after an oral administration of [14C] SPH3127, determine the main biotransformation pathways and main metabolites, quantitatively analyze the concentration of SPH3127 and main metabolites in plasma by validated LC-MS/MS method, and establish the pharmacokinetic parameters of SPH3127 and its main metabolites in plasma.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPH3127 | Experimental | Drug: SPH3127Oral 100 mg [14 c] SPH3127 mixed suspension |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male;
- Age: 18-45 years (inclusive);
- Body weight: the body weight of the subject is ≥ 50 kg, and the body mass index (BMI) is between 19 and 26 kg/m2 (inclusive);
- Subject who fully understands the objective, requirements, content, process and possible adverse reactions of this trial, volunteers for the trial, is able to complete the trial according to the trial requirements and comply with study instructions, and the process of obtaining informed consent conforms to GCP;
- Subject who can communicate well with the investigator and complete the trial according to the protocol.
Key exclusion criteria (22 listed)
- Those with clinically significant abnormalities in physical examination, vital signs, laboratory tests, thyroid function, 12-lead ECG, chest CT, abdominal ultrasound and other examinations;
- Those positive for combined detection of hepatitis B surface antigen or e antigen, hepatitis C virus antibody IgG, human immunodeficiency virus antigen/antibody and Treponema pallidum antibody;
- Screening for SARS-COV-2 infection: those with clinically significant abnormalities in C-reactive protein or positive for SARS-COV-2 RNA;
- Those who have used any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days prior to screening;
- Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines or food supplements within 14 days prior to screening;
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 |
|---|---|---|
| SPH3127Oral 100 mg [14 c] SPH3127 mixed suspension | Drug | SPH3127 |
Primary outcome
Cumulative excretion rate of total radioactive substances in excreta
Time frame: 240 hours
Cumulative excretion rate of total radioactive substances in excreta(urine and faeces).
The concentration of SPH3127 in plasma
Time frame: Sampling performed at predose, and 10 minute,20 minute,0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24,48,72,96,120,144and 168 hours post-dose.
The concentration of SPH3127 in plasma was determined by liquid chromatography tandem mass spectrometry (LC-MS/MS).
The total radioactivity in the collected plasma samples
Time frame: up to 168 hours
The total radioactivity in the collected plasma samples was measured directly by liquid scintillation counter.
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Predose and 240 hours post-dose.
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 Dec 2022.
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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 1/2 study testing SPH3127 in people with Primary Mild and Moderate Hypertension, run by Shanghai Pharmaceuticals Holding 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 5 inclusion and 22 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 Dec 2022. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cumulative excretion rate of total radioactive substances in excreta (time frame: 240 hours). 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 7 Dec 2022.