Erectile DysfunctionPhase 1NCT05976503
A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol
A Phase 1 study testing Tunodafil Hydrochloride Tablets and Alcohol in people with Erectile Dysfunction, run by Yangtze River Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is primarily to evaluate the effects of simultaneous administration of Tunodafil Hydrochloride Tablets with alcohol on blood pressure, pulse rate and pharmacokinetics in healthy Chinese male participants. 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
- Erectile Dysfunction
- What is being tested?
- Tunodafil Hydrochloride Tablets and Alcohol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2022to 21 Mar 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who can understand and are willing to strictly follow the clinical trial protocol to complete the trial and sign the informed consent;
- Male participants aged 18~45 years (including the cut-off value);
- Weight≥50.0kg; Body mass index (BMI) in the range of 19.0~26.0kg/m^2 (including the critical value);
- Good health, no history of respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and other serious diseases or chronic diseases;
- Do not plan to have children during the trial, and agree to use reliable contraception during the trial and for 3 months after the last study drug administration, and do not plan to donate sperm.
Who cannot join
- Allergic: allergic to drugs, food, pollen, alcohol, etc., known to be allergic to experimental drugs or other PDE5 inhibitors and excipients;
- Patients with difficulty swallowing tablets/capsules; Or according to 0.5g/kg body weight intake of alcohol (that is, 70kg body weight participants drink 35g pure alcohol, equivalent to 50 degrees of liquor about 70g) may be intoxicated; Or have special dietary requirements and cannot accept the standard diet provided by the research center;
- Patients who have a history of needle fainting and blood fainting, can not tolerate venous puncture blood collection and/or have difficulty in blood collection;
- Patients with abnormal color vision judged by researchers to have clinical significance; Or have known to have retinitis pigmentosa, macular degeneration, nonarteriotic anterior ischemic optic neuropathy (NAION) eye disease; Or have known fundus medical history that other investigators have deemed unsuitable for inclusion;
- People who have experienced sudden hearing loss or hearing loss in the past;
- Past or existing postural hypotension/syncope;
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- Clinically significant vital signs (reference value range: 90 mmHg≤systolic blood pressure (sitting) <140 mmHg, 60 mmHg≤diastolic blood pressure (sitting)<90 mmHg, 55 times/min≤pulse rate (resting)≤100 times/min, 35.5℃≤body temperature (axillary temperature)≤37.2℃; Participant to the judgment of the study physician); Or physical examination, 12-lead electrocardiogram, laboratory test results, the investigator judged that the abnormality is clinically significant;
- Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum specific antibody, human immunodeficiency virus antibody any abnormal clinical significance;
- Those who have used soft drugs (such as cannabis) within 3 months before screening or hard drugs (such as cocaine, amphetamines, Phencyclidine, etc.) within 1 year before screening; Or have a history of drug abuse; Or positive urine drug screening before randomization;
- Positive breath test for alcohol;
- Smokers who have smoked more than 5 cigarettes per day in the 3 months before screening or could not stop using any tobacco products during the test;
- Participants in any clinical trial within 3 months prior to screening;
- Those who have participated in blood donation and total blood donation or total blood loss≥400mL within 3 months before screening, or participated in blood donation and total blood donation≥200mL or total blood loss≥200mL within 1 month; Or receiving blood transfusion; Or plan to donate blood within 1 month after the end of this trial;
- Those who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the trial;
- Those who have received vaccination within 30 days prior to screening, or who plan to receive vaccination during the trial;
- Use of any CYP3A4/5 inhibitors or inducers (e.g., inhibitors-itraconazole, fluconazole, clarithromycin, ritonavir, cimetidine, diltiazem, etc.) within 28 days prior to randomization; Inducers-rifampicin, phenobarbital, carbamazepine);
- Those who have taken any prescription drugs, non-prescription drugs, health products, vitamins, or Chinese herbs within 14 days before randomization;
- Those who have eaten grapefruit, pomelo, dragon fruit, mango and other fruits or related products that affect metabolic enzymes within 7 days before randomization;
- People who ingested beverages or foods rich in caffeine or xanthine (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours before randomization;
- Patients who developed acute disease from the screening stage to before randomization;
- Participants judged by the investigator to be unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Blind, Placebo-controlled, Three-way Crossover Study to Evaluate the Potential Interaction of Tunodafil Hydrochloride Tablets and Alcohol in Healthy Chinese Male Participants
The purpose of this study is primarily to evaluate the effects of simultaneous administration of Tunodafil Hydrochloride Tablets with alcohol on blood pressure, pulse rate and pharmacokinetics in healthy Chinese male participants.
Read the detailed description
This study will be divided into two parts: pre-trial and formal trial. The pre-trial is a non-randomized, open design to evaluate the safety and tolerability of Tunodafil Hydrochloride Tablets in combination with alcohol in healthy male participants. Four participants will be taken 50mg or 100mg doses with alcohol. Supine blood pressure (systolic and diastolic), pulse rate, PK blood sample collection should be performed before and after administration, and the time point is the same as the formal trial.
The dosage of Tunodafil Hydrochloride Tablets in the formal trial will be determined based on the pre-trial results.
The formal trial is a single-center, randomized, blind, placebo-controlled, three-cycle crossover design, and 18 participants will be randomized to receive the following three treatments. The test is administered once per cycle and the washout period is 7 days:
Treatment A: A single oral dose of Tunodafil Hydrochloride Tablets 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 placebo 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 Tunodafil Hydrochloride Tablets plus an oral dose of placebo drink mixed with fruit juice.
For each treatment period, supine blood pressure and pulse rate will be measured at pre-dose and up to 24 hours post-dose. Blood will be collected at pre-dose and up to 24 hours post-dose.
- Conditions
- Erectile Dysfunction
- Being tested
- Tunodafil Hydrochloride Tablets, Placebo, Alcohol
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunodafil Hydrochloride TabletsDrug
100mg Tunodafil Hydrochloride Tablets
PlaceboDrug
Placebo
AlcoholOther
0.5 g/kg alcohol
| Study group | Role | What they receive |
|---|---|---|
| Tunodafil Hydrochloride plus alcohol | Experimental | Participants received 100 mg Tunodafil Hydrochloride Tablets plus 0.5 g/kg alcohol. Receives: Drug: Tunodafil Hydrochloride Tablets; Other: Alcohol |
| Placebo plus alcohol | Experimental | Participants received placebo plus 0.5 g/kg alcohol. Receives: Drug: Placebo; Other: Alcohol |
| Tunodafil Hydrochloride | Experimental | Participants received 100mg Tunodafil Hydrochloride Tablets. Receives: Drug: Tunodafil Hydrochloride Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change in systolic blood pressure (SBP)
Maximum change from baseline in decubitus (semi-decubitus) SBP.
Measured: 4 hours after treatment
Maximum change in diastolic blood pressure (DBP)
Maximum change from baseline in decubitus (semi-decubitus) DBP.
Measured: 4 hours after treatment
Maximum change in pulse
Maximum change from baseline in decubitus (semi-decubitus) position.
Measured: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine SBP
The area under effect-time curve (AUEC0- 4h) of supine SBP relative to baseline change.
Measured: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine DBP
The area under effect-time curve (AUEC0- 4h) of supine DBP relative to baseline change.
Measured: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of pulse
The area under effect-time curve (AUEC0- 4h) of pulse relative to baseline change.
Measured: 4 hours after treatment
Peak concentration (Cmax) of Tunodafil and metabolites M459
Measured: 24 hours after treatment
Area under drug time curve (AUC) of Tunodafil and metabolites M459
Measured: 24 hours after treatment
Peak concentration (Cmax) of alcohol
Measured: 8 hours after treatment
Secondary outcomes (1)
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
A treatment-emergent adverse events (TEAE) is defined as any unfavorable and unintended sign,symptom or disease temporally associated with the use of a study drug.
Measured: 7 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start19 Dec 2022
- Primary completion8 Mar 2023
- Study completion21 Mar 2023
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.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yangtze River Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976503
- Sponsor's protocol ID
- YZJ-YKNF-DDI-08
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 4 Aug 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 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blind, Placebo-controlled, Three-way Crossover Study to Evaluate the Potential Interaction of Tunodafil Hydrochloride Tablets and Alcohol in Healthy Chinese Male Participants
- ClinicalTrials.gov ID
- NCT05976503
- Acronym / sponsor ID
- YZJ-YKNF-DDI-08
- Conditions
- Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yangtze River Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 8 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 4 Aug 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 purpose of this study is primarily to evaluate the effects of simultaneous administration of Tunodafil Hydrochloride Tablets with alcohol on blood pressure, pulse rate and pharmacokinetics in healthy Chinese male participants.
Detailed description
This study will be divided into two parts: pre-trial and formal trial. The pre-trial is a non-randomized, open design to evaluate the safety and tolerability of Tunodafil Hydrochloride Tablets in combination with alcohol in healthy male participants. Four participants will be taken 50mg or 100mg doses with alcohol. Supine blood pressure (systolic and diastolic), pulse rate, PK blood sample collection should be performed before and after administration, and the time point is the same as the formal trial.
The dosage of Tunodafil Hydrochloride Tablets in the formal trial will be determined based on the pre-trial results.
The formal trial is a single-center, randomized, blind, placebo-controlled, three-cycle crossover design, and 18 participants will be randomized to receive the following three treatments. The test is administered once per cycle and the washout period is 7 days:
Treatment A: A single oral dose of Tunodafil Hydrochloride Tablets 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 placebo 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 Tunodafil Hydrochloride Tablets plus an oral dose of placebo drink mixed with fruit juice.
For each treatment period, supine blood pressure and pulse rate will be measured at pre-dose and up to 24 hours post-dose. Blood will be collected at pre-dose and up to 24 hours post-dose.
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 |
|---|---|---|
| Tunodafil Hydrochloride plus alcohol | Experimental | Drug: Tunodafil Hydrochloride Tablets, Other: AlcoholParticipants received 100 mg Tunodafil Hydrochloride Tablets plus 0.5 g/kg alcohol. |
| Placebo plus alcohol | Experimental | Drug: Placebo, Other: AlcoholParticipants received placebo plus 0.5 g/kg alcohol. |
| Tunodafil Hydrochloride | Experimental | Drug: Tunodafil Hydrochloride TabletsParticipants received 100mg Tunodafil Hydrochloride Tablets. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who can understand and are willing to strictly follow the clinical trial protocol to complete the trial and sign the informed consent;
- Male participants aged 18~45 years (including the cut-off value);
- Weight≥50.0kg; Body mass index (BMI) in the range of 19.0~26.0kg/m^2 (including the critical value);
- Good health, no history of respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and other serious diseases or chronic diseases;
- Do not plan to have children during the trial, and agree to use reliable contraception during the trial and for 3 months after the last study drug administration, and do not plan to donate sperm.
Key exclusion criteria (21 listed)
- Allergic: allergic to drugs, food, pollen, alcohol, etc., known to be allergic to experimental drugs or other PDE5 inhibitors and excipients;
- Patients with difficulty swallowing tablets/capsules; Or according to 0.5g/kg body weight intake of alcohol (that is, 70kg body weight participants drink 35g pure alcohol, equivalent to 50 degrees of liquor about 70g) may be intoxicated; Or have special dietary requirements and cannot accept the standard diet provided by the research center;
- Patients who have a history of needle fainting and blood fainting, can not tolerate venous puncture blood collection and/or have difficulty in blood collection;
- Patients with abnormal color vision judged by researchers to have clinical significance; Or have known to have retinitis pigmentosa, macular degeneration, nonarteriotic anterior ischemic optic neuropathy (NAION) eye disease; Or have known fundus medical history that other investigators have deemed unsuitable for inclusion;
- People who have experienced sudden hearing loss or hearing loss in the past;
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 |
|---|---|---|
| Tunodafil Hydrochloride Tablets100mg Tunodafil Hydrochloride Tablets | Drug | Tunodafil Hydrochloride, Tunodafil Hydrochloride plus alcohol |
| PlaceboPlacebo | Drug | Placebo plus alcohol |
| Alcohol0.5 g/kg alcohol | Other | Placebo plus alcohol, Tunodafil Hydrochloride plus alcohol |
Primary outcome
Maximum change in systolic blood pressure (SBP)
Time frame: 4 hours after treatment
Maximum change from baseline in decubitus (semi-decubitus) SBP.
Maximum change in diastolic blood pressure (DBP)
Time frame: 4 hours after treatment
Maximum change from baseline in decubitus (semi-decubitus) DBP.
Maximum change in pulse
Time frame: 4 hours after treatment
Maximum change from baseline in decubitus (semi-decubitus) position.
The area under effect-time curve (AUEC0- 4h) of supine SBP
Time frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine SBP relative to baseline change.
The area under effect-time curve (AUEC0- 4h) of supine DBP
Time frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of supine DBP relative to baseline change.
The area under effect-time curve (AUEC0- 4h) of pulse
Time frame: 4 hours after treatment
The area under effect-time curve (AUEC0- 4h) of pulse relative to baseline change.
Peak concentration (Cmax) of Tunodafil and metabolites M459
Time frame: 24 hours after treatment
Area under drug time curve (AUC) of Tunodafil and metabolites M459
Time frame: 24 hours after treatment
Peak concentration (Cmax) of alcohol
Time frame: 8 hours after treatment
1 secondary outcome
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Time frame: 7 days after treatment
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 4 Aug 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 Tunodafil Hydrochloride Tablets and Alcohol in people with Erectile Dysfunction, run by Yangtze River Pharmaceutical Group 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 21 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 4 Aug 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?
Maximum change in systolic blood pressure (SBP) (time frame: 4 hours after treatment). The study lists 9 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 4 Aug 2023.