Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

Study Overview
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Brief Summary
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safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation

Official Title
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Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients

Conditions
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Premature Ejaculation

Intervention / Treatment
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* Drug: dapoxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study History of premature ejaculation in the 6 months before study initiation History of intravaginal ejaculatory latency time (IELT) of < = 2 minutes in at least half of events Premature Ejaculation Diagnostic Tool (PEDT) > =11 6 domains of International Index of Erectile Function(IIEF) >= 21 Patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol Patient's partner must have a negative urine pregnancy test at time of screening Exclusion Criteria: Medical history which affects ADME in the past 3 years Clinically significant and active disorder in ophthalmic system, gastro-intestine, cardiovascular, respiratory system, endocrine system, autoimmune system or malignant tumor, Subjects with clinically significant observations considered as unsuitable based on medical judgment in the physical examination and clinical laboratory tests or a medical history History of psychological disease Clinically significant allergic disease Hypersensitivity to TCA, SSRIs(Clomipramine, sertraline, fluoxetine, dapoxetine) Taken dapoxetine within 3 months Using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin) Taken another investigational drug within 1 month History of drug abuse

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YHD1044 I<br> | Drug: dapoxetine<br>* multiple dosing 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine<br>* Other names: Priligy;|
| Experimental: YHD1044 III<br> | Drug: dapoxetine<br>* multiple dosing 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine<br>* Other names: Priligy;|
| Experimental: YHD1044 V<br> | Drug: dapoxetine<br>* multiple dosing 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine<br>* Other names: Priligy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | through physical examination, laboratory result, vital sign,ECG etc. | throughout the study up to day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy(IELT) | change from baseline in IELT at the Day 13, 28 | 13days, 28days | 
| Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F | Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt will be assessed. Samping time point: intensive sampling(Day1 2, Day14 15)& intermittent sampling(Day3 Day 28 except intensive sampling period) | specified timepoints in the protocol |