NCT03102398

Brief Summary

The purpose of this phase I/IIa study is to assess the safety and tolerability profile of TR399 in healthy volunteers and erectile dysfunction patients. This study will be conducted via a single-arm and open-label fashion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

November 22, 2017

Status Verified

June 1, 2017

Enrollment Period

10 months

First QC Date

March 20, 2017

Last Update Submit

November 21, 2017

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionPDE5 inhibitorSexual Dysfunction

Outcome Measures

Primary Outcomes (2)

  • Safety evaluation of TR399 assessed by Incidence of AEs and SAEs

    Phase I Incidence of AEs and SAEs

    24 days

  • Safety and efficacy evaluation of TR399 assessed by change from baseline to the last evaluation visit during the treatment period in score of IIEF-15 Erectile Function domain

    Phase IIa Change from baseline to the last evaluation visit during the treatment period in score of IIEF-15 Erectile Function domain

    83 days

Secondary Outcomes (11)

  • Safety evaluation of TR399 assessed by Maximum Plasma Concentration (Cmax)

    24 days

  • Safety evaluation of TR399 assessed by Area Under the Curve (AUC)

    24 days

  • Safety evaluation of TR399 assessed by Time of maximum concentration (Tmax)

    24 days

  • Change from baseline to post-treatment visits in score of IIEF-15 Erectile Function domain

    83 days

  • Change from baseline to post-treatment visits in SEP Question 2

    83 days

  • +6 more secondary outcomes

Study Arms (1)

Single-arm and Open-label Study

EXPERIMENTAL
Drug: TR-399 (5% Vardenafil HCl·3H2O, topical gel)

Interventions

TR-399 (5% Vardenafil HCl·3H2O, topical gel)DRUG

5% Vardenafil HCl·3H2O, topical gel, 2 drops (50ul, 2.5mg), q.d.

Single-arm and Open-label Study

Eligibility Criteria

Age20 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsDiagnosed and confirmed ED for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the National Institutes of Health (NIH) consensus report 1993
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Phase I
  • Male aged between 20\~40 years old ;
  • Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and electrocardiogram;
  • Body mass index (BMI) between 18.5 and 27, inclusive, (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]);
  • Clinically normal, including non-clinical significant abnormal, hematology, biochemistry and urinalysis determinations based on investigator's discretion;
  • Subject is willing and able to comply with study procedures and has signed informed consent.
  • With Erectile Function domain of the IIEF score of 25\~30
  • Phase IIa
  • Male aged between 20\~70 years old ;
  • Diagnosed and confirmed ED for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the National Institutes of Health (NIH) consensus report 1993;
  • With Erectile Function domain of the IIEF score of 13\~24;
  • Stable relationship for more than 3 months;
  • At least 4 sexual intercourse attempts at 4 different days during 4-week period prior the screening;
  • With a testosterone level ≥ 240 ng/dL (either naturally or through androgen replacement therapy);
  • Subject is willing and able to comply with study procedures and has signed informed consent.

You may not qualify if:

  • Phase I
  • Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of study product
  • Subject who has a history or evidence of a medical condition that would expose him to an undue risk of a significant adverse event or interfere with the assessments of safety or pharmacodynamics variables during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, musculoskeletal or hematological disease as determined by the clinical judgment of the investigator
  • Subject has received any investigational agent within 4 weeks prior to the screening visit
  • Subject has taken or potentially takes any prescription medication and/or over-the-counter medication from 1 week prior to the screening visit to the end of treatment (Day 15)
  • Sexual partner is a pregnant or lactating female or a female with childbearing potential not taking reliable contraceptive methods during study period Note: Acceptable contraceptive forms include
  • Established use of oral, injected or implanted hormonal methods of contraception
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS)
  • Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
  • Use of PDE-5 inhibitors within the last 2 weeks prior to the screening visit
  • Use of alpha blockers or nitrates within 2 weeks prior to the screening visit
  • Subject who has prolongation of QT interval \>500 ms (long QT syndrome)
  • Any of the following hematologic abnormalities:
  • Hemoglobin \< 10.0 g/dL
  • ANC \< 1,500/μL,
  • +62 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, 10449, Taiwan

RECRUITING

MeSH Terms

Conditions

Erectile DysfunctionSexual Dysfunction, Physiological

Interventions

Gels

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Central Study Contacts

Chia-Chi Lai

CONTACT

886-2-2809-8274camilla.lai@tritechbiopharm.com

Yee-Chien Liu

CONTACT

886-2-2809-8274tom.liu@tritechbiopharm.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

April 5, 2017

Study Start

March 31, 2017

Primary Completion

January 31, 2018

Study Completion

March 31, 2018

Last Updated

November 22, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)