Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

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

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

Study Overview

• Status: Completed
• Conditions: Premature Ejaculation
• Intervention / Treatment: Drug: dapoxetine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: August 17, 2011
• First Posted (Estimate): August 18, 2011

Study Record Updates

• Last Update Posted (Estimate): August 1, 2012
• Last Update Submitted That Met QC Criteria: July 31, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pregnancy Complications; Obstetric Labor Complications; Sexual Dysfunctions, Psychological; Obstetric Labor, Premature; Sexual Dysfunction, Physiological; Premature Birth; Premature Ejaculation
• Other Study ID Numbers: YCD173