Premature Ejaculation
Conditions
Brief summary
safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation
Interventions
DRUGdapoxetine
1. multiple dosing 2. 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | throughout the study up to day 28 | through physical examination, laboratory result, vital sign,ECG etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy(IELT) | 13days, 28days | change from baseline in IELT at the Day 13, 28 |
| Cmax(Cmax,ss), Cmin,ss, AUCinf, AUCt, Tmax, CL/F | specified timepoints in the protocol | 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) |
Countries
South Korea
Outcome results
None listed