Drug Drug InteractionPhase 1NCT05942365
A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
A Phase 1 study testing ZSP1273 in people with Drug Drug Interaction and Warfarin, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
This study is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction, Warfarin, Midazolam
- What is being tested?
- ZSP1273
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2023to 4 Aug 2023
- 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
- Adult, male and female participants, 18 to 55 years of age, inclusive, at first Check-In Visit;
- Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg(male) or >45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
Who cannot join
- Participants with a history of hypersensitivity to study drug(ZSP1273,warfarin, midazolam) or any component of study medication;
- Participants with a history of and/or signs and symptoms of current abnormal hemostasis or blood dyscrasia or abnormal prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time at screening;
- Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
- Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
- Those with clinically significant ECG abnormalities, or QTcF > 450ms in men and QTcF > 470ms in women;
- Participants who test positive at screening for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody or Syphilis spirochete-specific antibodies (TPPA);
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- Participants who test positive at Screening and/or admission (Day -1) for alcohol abuse.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- History of dysphagia or any gastrointestinal disorder that affect absorption
Trial locations and contacts
1 site in 1 country.
China1 site
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
About this study
Official title: A Phase 1, Open-Label, Two-Period，Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
This study is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam.
- Conditions
- Drug Drug Interaction, Warfarin, Midazolam
- Being tested
- ZSP1273
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1273Drug
Drug Warfarin oral Drug midazolam oral
| Study group | Role | What they receive |
|---|---|---|
| The DDI of ZSP1273 ,Warfarin and Midazolam | Experimental | Warfarin and midazolam will be co-administered alone and in combination with ZSP1273. Receives: Drug: ZSP1273 |
What is being measured
The primary outcome is the main question the study is designed to answer.
S-warfarin Maximum Plasma Concentration [Cmax]
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Measured: Day1 to Day28
Midazolam Maximum Plasma Concentration [Cmax]
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
Measured: Day1 to Day28
S-warfarin Area under the curve[AUC0-inf]
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Measured: Day1 to Day28
Midazolam Area under the curve[AUC0-inf]
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
Measured: Day1 to Day28
Secondary outcomes (1)
Number of participants with adverse events and serious adverse events
To assess the safety and tolerability of ZSP1273 following single and multiple-dose administration with and without midazolamin+S-warfarin in healthy participates
Measured: Day1 to Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start25 Jun 2023
- Primary completion21 Jul 2023
- Study completion4 Aug 2023
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.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942365
- Sponsor's protocol ID
- ZSP1273-23-11
- Status last verified
- Nov 2023
- First submitted
- 27 Jun 2023
- Last updated
- 6 Dec 2023
- 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 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Two-Period，Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam
- ClinicalTrials.gov ID
- NCT05942365
- Acronym / sponsor ID
- ZSP1273-23-11
- Conditions
- Drug Drug Interaction, Warfarin, Midazolam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2023 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 4 Aug 2023 (actual)
- First posted
- 12 Jul 2023 (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 is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The DDI of ZSP1273 ,Warfarin and Midazolam | Experimental | Drug: ZSP1273Warfarin and midazolam will be co-administered alone and in combination with ZSP1273. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult, male and female participants, 18 to 55 years of age, inclusive, at first Check-In Visit;
- Body mass index (BMI) ≥19 to ≤26kg/m2 and total body weight >50 kg(male) or >45kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.
Key exclusion criteria (9 listed)
- Participants with a history of hypersensitivity to study drug(ZSP1273,warfarin, midazolam) or any component of study medication;
- Participants with a history of and/or signs and symptoms of current abnormal hemostasis or blood dyscrasia or abnormal prothrombin time (PT), international normalized ratio (INR), or activated partial thromboplastin time at screening;
- Smoking more than 5 cigarettes per day within 3 months prior to screening，or who cannot stop using any tobacco products during the study period;
- Participants who donated blood/bleeding profusely (> 400 mL) 3 months prior to randomization;
- Those with clinically significant ECG abnormalities, or QTcF > 450ms in men and QTcF > 470ms in women;
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 |
|---|---|---|
| ZSP1273Drug Warfarin oral Drug midazolam oral | Drug | The DDI of ZSP1273 ,Warfarin and Midazolam |
Primary outcome
S-warfarin Maximum Plasma Concentration [Cmax]
Time frame: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Midazolam Maximum Plasma Concentration [Cmax]
Time frame: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
S-warfarin Area under the curve[AUC0-inf]
Time frame: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Midazolam Area under the curve[AUC0-inf]
Time frame: Day1 to Day28
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
1 secondary outcome
Number of participants with adverse events and serious adverse events
Time frame: Day1 to Day28
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 Dec 2023.
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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 ZSP1273 in people with Drug Drug Interaction and Warfarin, run by Guangdong Raynovent Biotech 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 9 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 Dec 2023. 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?
S-warfarin Maximum Plasma Concentration [Cmax] (time frame: Day1 to Day28). The study lists 4 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 6 Dec 2023.