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

NCT ID: NCT04969666

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2022-11-30

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IPED2015_dose 1

Active treatment

Group Type: EXPERIMENTAL

IPED2015

Intervention Type: DRUG

Active treatment

IPED2015_dose 2

Active treatment

Group Type: EXPERIMENTAL

IPED2015

Intervention Type: DRUG

Active treatment

Placebo

Placebo treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

IPED2015

Active treatment

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Initiator Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Westhead, MD

Role: PRINCIPAL_INVESTIGATOR

MAC UK

Central Contacts

Mikael Thomsen

Role: CONTACT

mt@initiatorpharma.com

23276134

Claus Olesen

Role: CONTACT

ceo@initiatorpharma.com

61260035

Other Identifiers

IPED2015CS02

Identifier Type: -

Identifier Source: org_study_id