A Phase II, Repeat Single Oral Dose Study of IPED2015 in Healthy Male Subjects With Erectile Dysfunction

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: IPED2015

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mikael Thomsen; Phone Number: 23276134; Email: mt@initiatorpharma.com
• Study Contact Backup: Name: Claus Olesen; Phone Number: 61260035; Email: ceo@initiatorpharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo treatment	Drug: Placebo; Placebo
Experimental: IPED2015_dose 1; Active treatment	Drug: IPED2015; Active treatment
Experimental: IPED2015_dose 2; Active treatment	Drug: IPED2015; Active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Index of Erectile Function (IIEF-15) scale	Erectile Dysfunction assessment	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rigiscan (diagnosis and assessment of male sexual impotence)	Device to assess erectile dysfunction	4 weeks
Semen analysis (check of quality of semen)	Analysis of tissue	4 weeks
Incidence of Treatment-Emergent Adverse Events	Assessment of patients health	4 weeks

Collaborators and Investigators

• Sponsor: Initiator Pharma
• Investigators: Principal Investigator: Paul Westhead, MD, MAC UK

Study record dates

Study Major Dates

• Study Start (Anticipated): August 4, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: IPED2015CS02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No