Clinical Trial Studying the Efficacy and Safety of IP2018 in Depressed, Erectile Dysfunction (ED) Patients

NCT04686916 | Unknown Phase 2

• 1 other identifier: IP2018CS01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IIa, randomised, double-blind, placebo-controlled, 3-period, crossover study to assess two single oral dose levels of IP2018. It is planned to enrol 24 patients. Patients will take part in three treatment periods, in which they will be randomised to receive either a single dose of IP2018 or a single dose of placebo in each treatment period.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Erectile Function

  Rigiscan device assessment of tumescence

  A 6 hours time interval after dosing

Secondary Outcomes (3)

• Safety assessment

  From randomisation to end of study participation

• Pharmacokinetics of IP2018

  From start to end of assessments

• Pharmacokinetics of IP2018

  From start to end of assessment

Study Arms (3)

IP2018_dose 1

EXPERIMENTAL

IP2018\_dose1

Drug: IP2018

IP2018_dose 2

EXPERIMENTAL

IP2018\_dose2

Drug: IP2018

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

IP2018 DRUG

Test drug

IP2018_dose 1; IP2018_dose 2

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Male patients with a diagnosis of mild to moderate depression and erectile dysfunction
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Male patients with a diagnosis of mild to moderate depression and ED as determined from the Hamilton depression scale score of 7 to 23 and International Index of Erectile Function (IIEF-5) score of 12 to 18, respectively, with a body mass index of 18 to 32 kg/m2 (inclusive), of any ethnic origin.

You may not qualify if:

• \- Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal (GI), haematological, endocrinological, metabolic, neurological, psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of Investigator, may place the patient at 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.

Sponsors & Collaborators

• Initiator Pharma: lead

Study Sites (1)

MAC

Manchester, United Kingdom

RECRUITING

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

• Giuseppe Fiore Fiore, MD

  MAC UK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claus Olesen, PhD

CONTACT

61260035; ceo@initiatorpharma.com

Mikael Thomsen, PhD

CONTACT

23276134; mt@initiatorpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 29, 2020
• Study Start: December 30, 2020
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: March 1, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)