A Phase II, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Repeat Single Oral Dose Study of IPED2015 or Placebo in Otherwise Healthy Male Subjects With Erectile Dysfunction

Initiator Pharma0 sites120 target enrollmentAugust 4, 2021

ConditionsErectile Dysfunction

InterventionsIPED2015 Placebo

DrugsIPED2015 Placebo

Overview

Phase: Phase 2
Intervention: IPED2015
Conditions: Erectile Dysfunction
Sponsor: Initiator Pharma
Enrollment: 120
Primary Endpoint: International Index of Erectile Function (IIEF-15) scale
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a Phase II, randomised, double-blind, parallel-group, placebo-controlled study to investigate the effects of repeat single oral doses of IPED2015 in otherwise healthy male subjects with ED.

Up to 120 subjects are planned to be enrolled into 3 groups. Group 1 is planned to consist of 60 subjects, Group 2 is planned to consist of 36 subjects and Group 3 is planned to consist of 24 subjects. Groups 1, 2 and 3 will be conducted in parallel. Each subject will be dosed on four occasions. There will be three study treatments of dose 1 of IPED2015, dose 2 of IPED2015 or matched placebo. In each group, subjects will be randomised evenly to each of the three study treatments and will receive the same treatment on each visit.

Detailed Description

The primary objective of this study is to investigate the effects of repeat single oral doses of IPED2015 on male subjects with erectile dysfunction (ED) on ability to develop and maintain an erection.

Registry

clinicaltrials.gov

Start Date

August 4, 2021

End Date

November 30, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Initiator Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Otherwise healthy male subjects with ED as determined from an IIEF-5 score of \<16, with a body mass index of 18 to 35 kg/m2 (inclusive), of any ethnic origin.
•Subject must have had at least one intent to have sexual intercourse during the last 3 months prior to Screening.

Exclusion Criteria

•Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion of drugs, or with the completion of treatment according to this Protocol.
•Clinically significant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening or Day -7 as judged by the Investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic, or renal disorder).
•Clinically significant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during the Screening visit may be repeated to confirm eligibility or judged to be clinically irrelevant for otherwise healthy subjects with ED.