Clinical trial NCT04969666: A Phase II, Repeat Single Oral Dose Study of IPED2015 in Healthy Male Subjects With Erectile Dysfunction
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Erectile Dysfunction
Lead sponsor: Initiator Pharma
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: International Index of Erectile Function (IIEF-15) scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Rigiscan (diagnosis and assessment of male sexual impotence)
timeFrame: 4 weeks
measure: Semen analysis (check of quality of semen)
timeFrame: 4 weeks
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: MAC UK
name: Paul Westhead, MD
role: PRINCIPAL_INVESTIGATOR
References: