A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol

NCT05976503 | Completed Phase 1

• 1 other identifier: YZJ-YKNF-DDI-08
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (9)

• Maximum change in systolic blood pressure (SBP)

  Maximum change from baseline in decubitus (semi-decubitus) SBP.

  4 hours after treatment

• Maximum change in diastolic blood pressure (DBP)

  Maximum change from baseline in decubitus (semi-decubitus) DBP.

  4 hours after treatment

• Maximum change in pulse

  Maximum change from baseline in decubitus (semi-decubitus) position.

  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.

  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.

  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.

  4 hours after treatment

• Peak concentration (Cmax) of Tunodafil and metabolites M459

  24 hours after treatment

• Area under drug time curve (AUC) of Tunodafil and metabolites M459

  24 hours after treatment

• Peak concentration (Cmax) of alcohol

  8 hours after treatment

Secondary Outcomes (1)

• Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

  7 days after treatment

Study Arms (3)

Tunodafil Hydrochloride plus alcohol

EXPERIMENTAL

Participants received 100 mg Tunodafil Hydrochloride Tablets plus 0.5 g/kg alcohol.

Drug: Tunodafil Hydrochloride Tablets; Other: Alcohol

Placebo plus alcohol

EXPERIMENTAL

Participants received placebo plus 0.5 g/kg alcohol.

Drug: Placebo; Other: Alcohol

Tunodafil Hydrochloride

EXPERIMENTAL

Participants received 100mg Tunodafil Hydrochloride Tablets.

Drug: Tunodafil Hydrochloride Tablets

Interventions

Tunodafil Hydrochloride Tablets DRUG

100mg Tunodafil Hydrochloride Tablets

Tunodafil Hydrochloride; Tunodafil Hydrochloride plus alcohol

Placebo DRUG

Placebo

Placebo plus alcohol

Alcohol OTHER

0.5 g/kg alcohol

Placebo plus alcohol; Tunodafil Hydrochloride plus alcohol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Sexes Eligible for the Study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• People who have experienced sudden hearing loss or hearing loss in the past;
• Past or existing postural hypotension/syncope;
• 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);

Sponsors & Collaborators

• Yangtze River Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 4, 2023
• Study Start: December 19, 2022
• Primary Completion: March 8, 2023
• Study Completion: March 21, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-07

Locations

CN (1)