NCT03240939

Brief Summary

A randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of YY-201 in comparison to Dutasteride and Tadalafil administered in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

November 24, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

April 24, 2017

Last Update Submit

November 21, 2017

Conditions

Benign Prostatic Hyperplasia

Keywords

DutasterideTadalafil

Outcome Measures

Primary Outcomes (1)

  • Cmax

    "Peak Plasma Concentration" of Dutasteride, tadalafil

    Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)

Secondary Outcomes (3)

  • Tmax

    Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)

  • t1/2β

    Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)

  • AUCinf

    Day 1 0 hour (pre-dose), 0.5 hour, 1hour, 1.5hour, 2hour, 2.5hour, 3hour, 3.5hour, 4hour, 5hour, 6hour, 8hour, 12hour, 24hour(Day 2), 32 hour, 48hour(Day 3), 72hour(Day 4), 96hour(Day 5), 144hour(Day 7), 192hour(Day 9), 240hour(Day 11)

Study Arms (2)

Dutasteride&Tadalafil

ACTIVE COMPARATOR

Dutasteride 0.5 mg capsule and Tadalafil 5 mg Tablet, single dose

Drug: Dutasteride 0.5 mgDrug: Tadalafil 5 mg

YY-201

EXPERIMENTAL

YY-201 capsule, singe dose

Drug: YY-201

Interventions

Dutasteride 0.5 mgDRUG

single dose

Dutasteride&Tadalafil
Tadalafil 5 mgDRUG

single dose

Dutasteride&Tadalafil
YY-201DRUG

single dose

YY-201

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 19 to 45 years
  • BMI score 19 kg/m2 to 28 kg/m2
  • SBP \< 140 mmHg and ≤ 90 mmHg or DBP \< 90 mmHg and ≥ 50 mmHg
  • Eligible according to the laboratory results of hematology, blood chemistry and urinalysis
  • Voluntarily signed the informed consent form

You may not qualify if:

  • Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months
  • History of hypersensitivity
  • history of Cardiovascular disease
  • History of degenerative Retina disease
  • Lactose intolerance
  • Medical history of vision loss
  • Clinically significant disorders of allergy, drug hypersensitivity reaction, hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system
  • Donated whole blood (transfusion, apheresis etc..) within 60 days
  • Participated and administered the investigational products in other clinical trial within 90 days
  • Taking drugs which may affect Clinical trial within 30 days
  • Smoked more than 10 cigarettes a day for past 30 days
  • Excessive alcohol consumption (\> 3 units/week, 1 unit)
  • Taking food which may affect Clinical trial within 7 days
  • Positive result from Urinary test
  • Positive result from Serum test
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

DutasterideTadalafil

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AzasteroidsSteroids, HeterocyclicSteroidsFused-Ring CompoundsPolycyclic CompoundsCarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Hyeong-Seok Lim, M.D.,Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

August 7, 2017

Study Start

March 27, 2017

Primary Completion

July 7, 2017

Study Completion

October 10, 2017

Last Updated

November 24, 2017

Record last verified: 2017-05

Locations

KR(1)