Drug Drug InteractionPhase 1/2NCT05359055
Drug-drug Interaction Study of SPH3127
A Phase 1/2 study testing SPH3127 tablet, Itraconazole and Rifampin in people with Drug Drug Interaction, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male 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
- Drug Drug Interaction
- What is being tested?
- SPH3127 tablet, Itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2021to 21 Jan 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
- Willing and able to provide written informed consent;
- Chinese Male ≥18 and ≤45 years；
- BMI≥18.5 and ≤26.0 kg/m2 and a weight ≥50.0 kg;
- Normal or no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the vital signs, physical examination, clinical laboratory tests, and 12-lead ECG.
- Subjects agreed to have no family planning during the study period and within 6 months after the last study drug administration, voluntarily take effective contraceptive measures and have no sperm donation plan. Non-drug contraceptive measures will be used voluntarily during the trial.
- Subjects can communicate well with investigators, understand and comply with the requirements of this trial.
Who cannot join
- Patients with diseases that need to be excluded, not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone, and other systems;
- History of allergic diseases;
- History of dysphagia or any gastrointestinal illness that affects drug absorption;
- Participated in clinical trials of other investigational drugs within 3 months prior to initial administration of the investigational drug;
- People who drink excessive tea, coffee and/or caffeinated beverages every day within 3 months before screening;
- Prescribed medications, over-the-counter medications, dietary supplements, or Chinese herbal medicines were taken within 14 days prior to initial administration of the study drug;
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- Unwilling to avoid vigorous exercise from 48 hours before the first administration of the study drug to the end of the study;
- Used of any drug that inhibits or induces hepatic metabolism of the drug in the 28 days prior to taking the study drug.
- Those who have special dietary requirements and cannot follow a uniform diet;
- Assessed by the investigators as unsuitable for participating in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, 610044
About this study
Official title: An Open-label, Fixed Sequence Study to Evaluate the Effects of Multi-dose of Itraconazole or Rifampin on the Pharmacokinetic Profiles of Single Dose of SPH3127 in Healthy Volunteers
A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
- Conditions
- Drug Drug Interaction
- Being tested
- SPH3127 tablet, Itraconazole, Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPH3127 tabletDrug
100mg once daily on Day 1 and Day 8
ItraconazoleDrug
200mg once daily from Day 3 to Day10.
SPH3127 tabletDrug
200mg once daily on Day 1 and Day 12.
RifampinDrug
600mg once daily from Day 3 to Day13.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | SPH3127 tablet, Itraconazole Receives: Drug: SPH3127 tablet; Drug: Itraconazole |
| Cohort 2 | Experimental | SPH3127 tablet, Rifampin Receives: Drug: SPH3127 tablet; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum serum concentration (Cmax) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Measured: Up to 14 days
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Measured: Up to 14 days
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Measured: Up to 14 days
Secondary outcomes (5)
Number of subjects with adverse event.
Adverse events, 12-lead ECG, clinical laboratory tests, physical examination and vital signs.
Measured: Up to 42 days
Time of maximum serum concentration (Tmax) SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Measured: Up to 14 days
Half-life (t1/2) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Measured: Up to 14 days
Apparent oral clearance (CL/F) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Measured: Up to 14 days
Apparent oral volume of distribution (Vz/F) of SPH3127
To characterize the PK (Pharmacokinetics) of SPH3127
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start13 Dec 2021
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qin Yu, Principal investigator, West China Second University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359055
- Sponsor's protocol ID
- SPH3127-104
- Status last verified
- Jul 2022
- First submitted
- 27 Apr 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed Sequence Study to Evaluate the Effects of Multi-dose of Itraconazole or Rifampin on the Pharmacokinetic Profiles of Single Dose of SPH3127 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05359055
- Acronym / sponsor ID
- SPH3127-104
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 3 May 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.
A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SPH3127 tablet, Drug: ItraconazoleSPH3127 tablet, Itraconazole |
| Cohort 2 | Experimental | Drug: SPH3127 tablet, Drug: RifampinSPH3127 tablet, Rifampin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent;
- Chinese Male ≥18 and ≤45 years；
- BMI≥18.5 and ≤26.0 kg/m2 and a weight ≥50.0 kg;
- Normal or no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the vital signs, physical examination, clinical laboratory tests, and 12-lead ECG.
- Subjects agreed to have no family planning during the study period and within 6 months after the last study drug administration, voluntarily take effective contraceptive measures and have no sperm donation plan. Non-drug contraceptive measures will be used voluntarily during the trial.
Key exclusion criteria (10 listed)
- Patients with diseases that need to be excluded, not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone, and other systems;
- History of allergic diseases;
- History of dysphagia or any gastrointestinal illness that affects drug absorption;
- Participated in clinical trials of other investigational drugs within 3 months prior to initial administration of the investigational drug;
- People who drink excessive tea, coffee and/or caffeinated beverages every day within 3 months before 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 |
|---|---|---|
| SPH3127 tablet100mg once daily on Day 1 and Day 8 | Drug | Cohort 1 |
| Itraconazole200mg once daily from Day 3 to Day10. | Drug | Cohort 1 |
| SPH3127 tablet200mg once daily on Day 1 and Day 12. | Drug | Cohort 2 |
| Rifampin600mg once daily from Day 3 to Day13. | Drug | Cohort 2 |
Primary outcome
Maximum serum concentration (Cmax) of SPH3127
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127
Time frame: Up to 14 days
To characterize the PK (Pharmacokinetics) of SPH3127
5 secondary outcomes
Number of subjects with adverse event.
Time frame: Up to 42 days
Time of maximum serum concentration (Tmax) SPH3127
Time frame: Up to 14 days
Half-life (t1/2) of SPH3127
Time frame: Up to 14 days
Apparent oral clearance (CL/F) of SPH3127
Time frame: Up to 14 days
Apparent oral volume of distribution (Vz/F) of SPH3127
Time frame: Up to 14 days
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 29 Jul 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.
Qin Yu principal investigator
West China Second University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SPH3127 tablet, Itraconazole and Rifampin in people with Drug Drug Interaction, 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 6 inclusion and 10 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 29 Jul 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?
Maximum serum concentration (Cmax) of SPH3127 (time frame: Up to 14 days). 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 29 Jul 2022.