A Study of the Hemodynamic Interactions of TPN171H Tablets & Alcohol in Healthy Male Subjects

NCT05316428 | Completed Phase 1

• 1 other identifier: TPN171H-08
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol; Phosphodiesterase Inhibitor; Erectile Dysfunction

Keywords

Phase I; Crossover Study; Alcohol; TPN171H

Outcome Measures

Primary Outcomes (3)

• Maximum change in blood pressure (SBP and DBP)

  Maximum change in decubitus (semi-decubitus) blood pressure (SBP and DBP) from baseline

  48 hours after treatment

• Maximum change in pulse

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

  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.

  4 hours after treatment

Study Arms (3)

alcohol plus TPN171H

EXPERIMENTAL

0.5 g/Kg alcohol plus 10 mg TPN171H tablet

Drug: TPN171H tablet plus alcohol

alcohol

EXPERIMENTAL

0.5 g/kg alcohol

Other: alcohol

TPN171H

EXPERIMENTAL

10 mg TPN171H tablet

Drug: TPN171H tablet

Interventions

TPN171H tablet plus alcohol DRUG

10 mg TPN171H tablet QD plus 0.5 g/kg alcohol

alcohol plus TPN171H

alcohol OTHER

0.5 g/kg alcohol

alcohol

TPN171H tablet DRUG

10 mg TPN171H tablet QD

TPN171H

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• 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;
• 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.

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, 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 Officials

• Chen Yu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

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: February 8, 2022
• First Posted: April 7, 2022
• Study Start: February 24, 2022
• Primary Completion: April 2, 2022
• Study Completion: April 6, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-02

Locations

CN (1)