A Study to Characterize the Pharmacokinetics of DA-8031 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01104948
First received: April 12, 2010
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing, dose-escalation study. The study is designed to describe the relationship between multiple doses and pharmacokinetic parameters of DA-8031 as well as safety profile.


Condition Intervention Phase
Premature Ejaculatory Dysfunction
Drug: DA-8031
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Dose Block-randomized, Double-blind, Placebo-controlled, Single/Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic Characteristics of DA-8031 After Oral Administration in Healthy Male Subjects

Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • To characterize the pharmacokinetic parameters such as AUC(Area under concentration-time curve), Cmax, Tmax, T1/2, fe, and CL/F of DA-8031 by as assessment of plasma and urine concentration

Secondary Outcome Measures:
  • To evaluate the safety and tolerance of DA-8031 by assessment of vital signs, clinical laboratory tests, physical examinations, ECG findings, and adverse events collected by investigator questionnaire and subjects spontaneous report

Enrollment: 106
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-8031 Drug: DA-8031
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20-45 years healthy male subjects
  • Body weight :60-90kg, BMI between 18.5-25

Exclusion Criteria:

  • show SBP(Systolic Blood Pressure) =<100mmHg or >=140mmHg, or DBP(Diastolic Blood Pressure)=<60mmHg or >=90mmHg, or tachycardia (PR(Pulse Rate)>=100times/min)
  • have a history of drug abuse or show positive for drug abuse or cotinine at urine screening
  • smokers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104948

Locations
Korea, Republic of
Clinical Research Institute, Seoul National University Hospital
Seoul, Chongno-Gu, Yon-Gon Dong 28, Korea, Republic of, 110-744
Sponsors and Collaborators
Dong-A ST Co., Ltd.
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01104948     History of Changes
Other Study ID Numbers: DA-8031
Study First Received: April 12, 2010
Last Updated: July 10, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014