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Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

Sponsor
Yuhan Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01419470
Collaborator
(none)
24
Enrollment
1
Location
3
Arms
14.9
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
Official Title:
Phase Ⅰ/Ⅱ Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044 After Oral Administration in Premature Ejaculation Patients
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
May 1, 2012
Actual Study Completion Date :
May 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: YHD1044 I

Drug: dapoxetine
multiple dosing 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
Other Names:
  • Priligy

    		•
    Experimental: YHD1044 III

    Drug: dapoxetine
    multiple dosing 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
    Other Names:
  • Priligy

    		•
    Experimental: YHD1044 V

    Drug: dapoxetine
    multiple dosing 12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine
    Other Names:
  • Priligy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability [throughout the study up to day 28]

      through physical examination, laboratory result, vital sign,ECG etc.

    Secondary Outcome Measures

    1. Efficacy(IELT) [13days, 28days]

      change from baseline in IELT at the Day 13, 28

    2. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung medical center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yuhan Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuhan Corporation
    ClinicalTrials.gov Identifier:
    NCT01419470
    Other Study ID Numbers:
    • YCD173
    First Posted:
    Aug 18, 2011
    Last Update Posted:
    Aug 1, 2012
    Last Verified:
    Jul 1, 2012
    Additional relevant MeSH terms:
    Premature Birth
    Premature Ejaculation

    Study Results

    No Results Posted as of Aug 1, 2012