AlcoholPhase 1NCT05316428
A Study of the Hemodynamic Interactions of TPN171H Tablets & Alcohol in Healthy Male Subjects
A Phase 1 study testing TPN171H tablet plus alcohol, alcohol and TPN171H tablet in people with Alcohol and Phosphodiesterase Inhibitor, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
The purpose of this study is primarily to evaluate the effects of taking TPN171H tablets with alcohol on blood pressure, pulse,and pharmacokinetic in Chinese healthy male subjects. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol, Phosphodiesterase Inhibitor, Erectile Dysfunction
- What is being tested?
- TPN171H tablet plus alcohol, alcohol and TPN171H tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2022to 6 Apr 2022
- 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign and abide by the contents of the informed consent;
- Adult male subjects, either 21 to 45 years of age,
- Body weight ≥55 kg; Body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including the critical value);
- Subjects must agree to use at least one method of birth control for at least three months from the time of the first dose to at least the last;
- Normal or abnormal important indicators of physical examination, vital signs examination, electrocardiogram examination and laboratory examination have no clinical significance as judged by the researcher.
Who cannot join
- Unable to consume alcohol according to 0.5 g/kg (body weight);
- After ingestion of 0.5 g/kg alcohol, the instrument showed alcohol concentration ≥120 mg/100 mL after exhalation, or moderate or severe acute alcoholism, which was judged by the investigator to be unfit to continue to participate in the study (see Appendix 1 for clinical classification of acute alcoholism);
- Systolic pressure in decubitus (semi-decubitus) position < 90 or ≥140 mmHg; Diastolic pressure in decubitus (semi-decubitus) position < 60 or ≥90 mmHg；
- Known allergic history, patients with allergic diseases or allergic predisposition to the study product or any of its components or related product;
- May significantly affect drug absorption, distribution, metabolism and excretion of any surgical situation or condition, or may pose a hazard to participate in research subjects of any surgical situation or condition, such as the history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding history etc. (except for gallbladder removal);
- Patients with myocardial infarction, severe/unstable angina pectoris, coronary artery/peripheral artery bypass graft, congestive heart failure, severe arrhythmias, and cerebrovascular accidents, including transient ischemic attack, within 6 months prior to the administration of the study drug;
Show all 18Show fewer
- Those who had used any drugs to inhibit or induce drug metabolism in the liver within 4 weeks before enrollment or needed to use any drugs in combination during the study period; Patients taking nitrates in any form;
- Known history of the following eye diseases: non-avascular ischemic optic neuropathy (NAION), abnormal color vision, hereditary retinal degeneration (e.g. Retinitis pigmentosa), macular degeneration;
- Known history of sudden hearing loss or loss;
- A history of postural hypotension;
- Patients with blood loss >400 mL within 3 months before inclusion;
- Participated in clinical research of other drugs or medical devices within 3 months prior to inclusion;
- Current or previous alcoholics (drinking more than 14 standard units per week. 1 standard unit containing 14 g alcohol, such as 360 mL beer or 45 mL 40% spirits or 150 mL wine), or positive breath test for alcohol;
- Have a history of drug use or have been screened positive for drug abuse;
- Smokers who smoked more than 10 cigarettes a day within 6 months prior to inclusion;
- Human immunodeficiency virus antibody (HIV), hepatitis C virus antibody (anti-HCV), hepatitis B surface antigen (HBsAg), treponema pallidum antibody (anti-TP) positive;
- Alcohol sensitivity test positive;
- There were other factors that the investigator considered inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blind, Placebo-controlled, Three-way Crossover Study Evaluating the Interaction of TPN171H Tablets and Alcohol in Healthy Chinese Male Subjects
The purpose of this study is primarily to evaluate the effects of taking TPN171H tablets with alcohol on blood pressure, pulse,and pharmacokinetic in Chinese healthy male subjects.
Read the detailed description
This study will be divided into two parts: pre-test and formal test. The pre-trial is an open design to evaluate the safety and tolerability of TPN171H tablets in combination with alcohol in healthy male subjects. Two subjects at 5 mg and 10 mg doses will be taken with alcohol, blood pressure (SBP and DBP), pulse, alcohol breath monitoring and PK blood sample collection were required, and the time point was the same as the formal test.
The dosage of TPN171H tablets in the formal trial will be determined according to the preliminary test results.
The formal trial is a single-centre, blind, randomized, placebo-controlled, three-period, three-way crossover study, in which each subject will be randomized to receive each of the following three treatments with a washout period of at least 3 days between treatments:
Treatment A: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
Treatment C: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of placebo drink mixed with fruit juice.
For each treatment period, supine blood pressure and pulse rate will be measured pre-dose and every 15 minutes for 4 hours post-dose,and at 6h,8h,24h and 48h post-dose. Alcohol levels using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3 treatments by designated unblinded personnel.
- Conditions
- Alcohol, Phosphodiesterase Inhibitor, Erectile Dysfunction
- Being tested
- TPN171H tablet plus alcohol, alcohol, TPN171H tablet
- Keywords
- Phase I, Crossover Study, Alcohol, TPN171H
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPN171H tablet plus alcoholDrug
10 mg TPN171H tablet QD plus 0.5 g/kg alcohol
alcoholOther
0.5 g/kg alcohol
TPN171H tabletDrug
10 mg TPN171H tablet QD
| Study group | Role | What they receive |
|---|---|---|
| alcohol plus TPN171H | Experimental | 0.5 g/Kg alcohol plus 10 mg TPN171H tablet Receives: Drug: TPN171H tablet plus alcohol |
| alcohol | Experimental | 0.5 g/kg alcohol Receives: Other: alcohol |
| TPN171H | Experimental | 10 mg TPN171H tablet Receives: Drug: TPN171H tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change in blood pressure (SBP and DBP)
Maximum change in decubitus (semi-decubitus) blood pressure (SBP and DBP) from baseline
Measured: 48 hours after treatment
Maximum change in pulse
Maximum change from baseline in decubitus (semi-decubitus) position;
Measured: 48 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine systolic (SBP) and diastolic (DBP) blood pressure, and pulse
The area under effect-time curve (AUEC0- 4h) of supine systolic (SBP) and diastolic (DBP) blood pressure, and pulse relative to baseline change.
Measured: 4 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start24 Feb 2022
- Primary completion2 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chen Yu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316428
- Sponsor's protocol ID
- TPN171H-08
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 23 May 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 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, Placebo-controlled, Three-way Crossover Study Evaluating the Interaction of TPN171H Tablets and Alcohol in Healthy Chinese Male Subjects
- ClinicalTrials.gov ID
- NCT05316428
- Acronym / sponsor ID
- TPN171H-08
- Conditions
- Alcohol, Phosphodiesterase Inhibitor, Erectile Dysfunction
- Keywords
- Phase I, Crossover Study, Alcohol, TPN171H
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 2 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 7 Apr 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.
The purpose of this study is primarily to evaluate the effects of taking TPN171H tablets with alcohol on blood pressure, pulse,and pharmacokinetic in Chinese healthy male subjects.
Detailed description
This study will be divided into two parts: pre-test and formal test. The pre-trial is an open design to evaluate the safety and tolerability of TPN171H tablets in combination with alcohol in healthy male subjects. Two subjects at 5 mg and 10 mg doses will be taken with alcohol, blood pressure (SBP and DBP), pulse, alcohol breath monitoring and PK blood sample collection were required, and the time point was the same as the formal test.
The dosage of TPN171H tablets in the formal trial will be determined according to the preliminary test results.
The formal trial is a single-centre, blind, randomized, placebo-controlled, three-period, three-way crossover study, in which each subject will be randomized to receive each of the following three treatments with a washout period of at least 3 days between treatments:
Treatment A: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
Treatment B: a single oral dose of one placebo tablet plus an oral dose of alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).
Treatment C: a single oral dose of one10 mg or 5 mg TPN171H tablet plus an oral dose of placebo drink mixed with fruit juice.
For each treatment period, supine blood pressure and pulse rate will be measured pre-dose and every 15 minutes for 4 hours post-dose,and at 6h,8h,24h and 48h post-dose. Alcohol levels using a breathalyzer will be measured at pre-dose and up to 8 hours post dose during all 3 treatments by designated unblinded personnel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alcohol plus TPN171H | Experimental | Drug: TPN171H tablet plus alcohol0.5 g/Kg alcohol plus 10 mg TPN171H tablet |
| alcohol | Experimental | Other: alcohol0.5 g/kg alcohol |
| TPN171H | Experimental | Drug: TPN171H tablet10 mg TPN171H tablet |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntarily sign and abide by the contents of the informed consent;
- Adult male subjects, either 21 to 45 years of age,
- Body weight ≥55 kg; Body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including the critical value);
- Subjects must agree to use at least one method of birth control for at least three months from the time of the first dose to at least the last;
- Normal or abnormal important indicators of physical examination, vital signs examination, electrocardiogram examination and laboratory examination have no clinical significance as judged by the researcher.
Key exclusion criteria (18 listed)
- Unable to consume alcohol according to 0.5 g/kg (body weight);
- After ingestion of 0.5 g/kg alcohol, the instrument showed alcohol concentration ≥120 mg/100 mL after exhalation, or moderate or severe acute alcoholism, which was judged by the investigator to be unfit to continue to participate in the study (see Appendix 1 for clinical classification of acute alcoholism);
- Systolic pressure in decubitus (semi-decubitus) position < 90 or ≥140 mmHg; Diastolic pressure in decubitus (semi-decubitus) position < 60 or ≥90 mmHg；
- Known allergic history, patients with allergic diseases or allergic predisposition to the study product or any of its components or related product;
- May significantly affect drug absorption, distribution, metabolism and excretion of any surgical situation or condition, or may pose a hazard to participate in research subjects of any surgical situation or condition, such as the history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding history etc. (except for gallbladder removal);
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 |
|---|---|---|
| TPN171H tablet plus alcohol10 mg TPN171H tablet QD plus 0.5 g/kg alcohol | Drug | alcohol plus TPN171H |
| alcohol0.5 g/kg alcohol | Other | alcohol |
| TPN171H tablet10 mg TPN171H tablet QD | Drug | TPN171H |
Primary outcome
Maximum change in blood pressure (SBP and DBP)
Time frame: 48 hours after treatment
Maximum change in decubitus (semi-decubitus) blood pressure (SBP and DBP) from baseline
Maximum change in pulse
Time frame: 48 hours after treatment
Maximum change from baseline in decubitus (semi-decubitus) position;
The area under effect-time curve (AUEC0- 4h) of supine systolic (SBP) and diastolic (DBP) blood pressure, and pulse
Time frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine systolic (SBP) and diastolic (DBP) blood pressure, and pulse relative to baseline change.
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 23 May 2022.
Related trials for Alcohol
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
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.
Chen Yu 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 tablet plus alcohol, alcohol and TPN171H tablet in people with Alcohol and Phosphodiesterase Inhibitor, 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 18 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 23 May 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 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?
Maximum change in blood pressure (SBP and DBP) (time frame: 48 hours after treatment). 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 23 May 2022.