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

Primary Purpose

Erectile Dysfunction

Status

Recruiting

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

IP2018

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Sites / Locations

MACRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

IP2018_dose 1

IP2018_dose 2

Placebo

Arm Description

IP2018_dose1

IP2018_dose2

Placebo

Outcomes

Primary Outcome Measures

Erectile Function

Rigiscan device assessment of tumescence

Secondary Outcome Measures

Safety assessment

Clinical safety data from AE reporting, 12-lead electrocardiograms (ECGs), vital signs (standing and supine blood pressure, heart rate and oral temperature [supine only]), physical examinations and clinical laboratory evaluations

Pharmacokinetics of IP2018

AUC

Pharmacokinetics of IP2018

Tmax

Full Information

NCT ID

NCT04686916

First Posted

December 9, 2020

Last Updated

February 28, 2023

Sponsor

Initiator Pharma

1. Study Identification

Unique Protocol Identification Number

NCT04686916

Brief Title

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

Official Title

A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial Studying the Efficacy and Safety of IP2018 in Young, Depressed, Erectile Dysfunction (ED) Patients

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 30, 2020 (Actual)

Primary Completion Date

July 30, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Initiator Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IP2018_dose 1

Arm Type

Experimental

Arm Description

IP2018_dose1

Arm Title

IP2018_dose 2

Arm Type

Experimental

Arm Description

IP2018_dose2

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

IP2018

Intervention Description

Test drug

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Erectile Function

Description

Rigiscan device assessment of tumescence

Time Frame

A 6 hours time interval after dosing

Secondary Outcome Measure Information:

Title

Safety assessment

Description

Time Frame

From randomisation to end of study participation

Title

Pharmacokinetics of IP2018

Description

AUC

Time Frame

From start to end of assessments

Title

Pharmacokinetics of IP2018

Description

Tmax

Time Frame

From start to end of assessment

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male patients with a diagnosis of mild to moderate depression and erectile dysfunction

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claus Olesen, PhD

Phone

61260035

ceo@initiatorpharma.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mikael Thomsen, PhD

Phone

23276134

mt@initiatorpharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Fiore Fiore, MD

Organizational Affiliation

MAC UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

MAC

City

Manchester

Country

United Kingdom

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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