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

NCT04969666 | Unknown Phase 2

• 1 other identifier: IPED2015CS02
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function (IIEF-15) scale

  Erectile Dysfunction assessment

  4 weeks

Secondary Outcomes (3)

• Rigiscan (diagnosis and assessment of male sexual impotence)

  4 weeks

• Semen analysis (check of quality of semen)

  4 weeks

• Incidence of Treatment-Emergent Adverse Events

  4 weeks

Study Arms (3)

IPED2015_dose 1

EXPERIMENTAL

Active treatment

Drug: IPED2015

IPED2015_dose 2

EXPERIMENTAL

Active treatment

Drug: IPED2015

Placebo

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

Interventions

IPED2015 DRUG

Active treatment

IPED2015_dose 1; IPED2015_dose 2

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Initiator Pharma: lead

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Paul Westhead, MD

  MAC UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikael Thomsen

CONTACT

23276134; mt@initiatorpharma.com

Claus Olesen

CONTACT

61260035; ceo@initiatorpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 21, 2021
• Study Start: August 4, 2021
• Primary Completion: September 30, 2022
• Study Completion: November 30, 2022
• Last Updated: July 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share