Erectile DysfunctionPhase 1NCT06090123
Drug-Drug Interaction (DDI) Study for TPN171H
A Phase 1 study testing TPN171H, Itraconazole and Rifampicin in people with Erectile Dysfunction, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
The primary objective of this study was to assess the effect of rifampicin,a cytochrome P450 3A4 enzyme (CYP3A4) induction, on the pharmacokinetics (PK) of TPN171H in chinese healthy male subjects ,and assess the effect of itraconazole，cytochrome P450 3A4 enzyme (CYP3A4) induction on the PK of TPN171H in chinese… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- TPN171H, Itraconazole and Rifampicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 2 Sep 2020
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 40 years;
- Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg;
- Physical examination, vital signs examination, ECG, laboratory examination results were normal or abnormal without clinical significance;
- Take reliable contraceptive measures during the trial and within three months after taking the drug;
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.
Who cannot join
- Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
- Clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
- Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
- A history of postural hypotension;
- Patients with blood loss ≥400 mL within 3 months before inclusion;
- Taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health care products within 2 weeks before administration;
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- Participated in other drug clinical trials and received trial drugs within 3 months before administration;
- Positive results of alcohol breath test, or current/previous alcoholics (drinking more than 21 standard units per week. 1 standard unit contains 14 g of alcohol, such as 360 mL of beer or 45 mL of 40% spirits or 150 mL wine);
- Smoking more than 10 cigarettes per day ;
- Positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
- Patients with clinically significant Chest x-ray (posterioranterior) abnormalities;
- The investigator believes that there are other factors that are not suitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: A Phase 1,Parallel Assignment,Fixed-Sequence Study to Assess the Effect of Itraconazole, Rifampicin on the Pharmacokinetics of TPN171H in Healthy Subjects
The primary objective of this study was to assess the effect of rifampicin,a cytochrome P450 3A4 enzyme (CYP3A4) induction, on the pharmacokinetics (PK) of TPN171H in chinese healthy male subjects ,and assess the effect of itraconazole，cytochrome P450 3A4 enzyme (CYP3A4) induction on the PK of TPN171H in chinese healthy male subjects
- Conditions
- Erectile Dysfunction
- Being tested
- TPN171H, Itraconazole, Rifampicin
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPN171HDrug
Sequence 1：Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.
Sequence 2：Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
ItraconazoleDrug
Sequence 1：Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.
RifampicinDrug
Sequence 2：Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
| Study group | Role | What they receive |
|---|---|---|
| TPN171H and Itraconazole | Experimental | Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6. Receives: Drug: TPN171H; Drug: Itraconazole |
| TPN171H and Rifampicin | Experimental | Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10. Receives: Drug: TPN171H; Drug: Rifampicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of TPN171H
Maximum Plasma Concentration (Cmax) of TPN171H
Measured: 48 hours after taking TPN171H
AUC of TPN171H
Area under the plasma concentration versus time curve (AUC) of TPN171H
Measured: 48 hours after taking TPN171H
Secondary outcomes (5)
Adverse events
Number of Participants With treatment-related Adverse Events and Serious Adverse Events
Measured: Up to Day 13 from taking TPN171H for part one(Itraconazole), up to Day 17 from taking TPN171H for part two(Rifampicin)
The pharmacokinetic parameters (TPN171H) :Tmax
The pharmacokinetic parameters (TPN171H) :Tmax
Measured: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :T1/2
The pharmacokinetic parameters (TPN171H) :T1/2
Measured: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :CL/F
The pharmacokinetic parameters (TPN171H) :CL/F
Measured: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :Vz/F
The pharmacokinetic parameters (TPN171H) :Vz/F
Measured: 48 hours after taking TPN171H
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jan 2020
- Primary completion27 Apr 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gangyi Liu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090123
- Sponsor's protocol ID
- TPN171H-05
- Status last verified
- Oct 2023
- First submitted
- 21 Jun 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1,Parallel Assignment,Fixed-Sequence Study to Assess the Effect of Itraconazole, Rifampicin on the Pharmacokinetics of TPN171H in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06090123
- Acronym / sponsor ID
- TPN171H-05
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 19 Oct 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.
The primary objective of this study was to assess the effect of rifampicin,a cytochrome P450 3A4 enzyme (CYP3A4) induction, on the pharmacokinetics (PK) of TPN171H in chinese healthy male subjects ,and assess the effect of itraconazole，cytochrome P450 3A4 enzyme (CYP3A4) induction on the PK of TPN171H in chinese healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPN171H and Itraconazole | Experimental | Drug: TPN171H, Drug: ItraconazoleSingle dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6. |
| TPN171H and Rifampicin | Experimental | Drug: TPN171H, Drug: RifampicinSingle dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male subjects between the ages of 18 and 40 years;
- Body Mass Index of 19 to 26 kg/m2; Body weight no less than 50 kg;
- Physical examination, vital signs examination, ECG, laboratory examination results were normal or abnormal without clinical significance;
- Take reliable contraceptive measures during the trial and within three months after taking the drug;
- Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign the written informed consent, and can complete the whole trial process according to the test requirements.
Key exclusion criteria (12 listed)
- Allergies to test preparations, any of their ingredients, and related preparations; With allergies or allergic diseases;
- Clear diseases of the central nervous system, cardiovascular system, digestive system (including those with severe fatty liver in B-ultrasound examination), respiratory system, urinary system, blood system, metabolic disorders, etc. and require medical intervention or other unsuitable clinical trials Those with tested diseases (such as history of mental illness, etc.); those with a history of orthostatic hypotension;
- Blurred vision or a history of the following ocular diseases: nonvascular anterior ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (such as retinitis pigmentosa), macular degeneration;
- A history of postural hypotension;
- Patients with blood loss ≥400 mL within 3 months before inclusion;
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 |
|---|---|---|
| TPN171HSequence 1：Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6. Sequence 2：Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10. | Drug | TPN171H and Itraconazole, TPN171H and Rifampicin |
| ItraconazoleSequence 1：Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6. | Drug | TPN171H and Itraconazole |
| RifampicinSequence 2：Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10. | Drug | TPN171H and Rifampicin |
Primary outcome
Cmax of TPN171H
Time frame: 48 hours after taking TPN171H
Maximum Plasma Concentration (Cmax) of TPN171H
AUC of TPN171H
Time frame: 48 hours after taking TPN171H
Area under the plasma concentration versus time curve (AUC) of TPN171H
5 secondary outcomes
Adverse events
Time frame: Up to Day 13 from taking TPN171H for part one(Itraconazole), up to Day 17 from taking TPN171H for part two(Rifampicin)
The pharmacokinetic parameters (TPN171H) :Tmax
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :T1/2
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :CL/F
Time frame: 48 hours after taking TPN171H
The pharmacokinetic parameters (TPN171H) :Vz/F
Time frame: 48 hours after taking TPN171H
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 19 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Gangyi Liu principal investigator
Xuhui Central Hospital, Shanghai
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 TPN171H, Itraconazole and Rifampicin in people with Erectile Dysfunction, run by Vigonvita Life Sciences 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 12 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 19 Oct 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?
Cmax of TPN171H (time frame: 48 hours after taking TPN171H). The study lists 2 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 19 Oct 2023.