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

Study Overview
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Brief Summary
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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.

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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Drug: IP2018
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IP2018_dose 1<br>IP2018_dose1 | Drug: IP2018<br>* Test drug<br>|
| Experimental: IP2018_dose 2<br>IP2018_dose2 | Drug: IP2018<br>* Test drug<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Function | Rigiscan device assessment of tumescence | A 6 hours time interval after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From randomisation to end of study participation | 
| Pharmacokinetics of IP2018 | AUC | From start to end of assessments | 
| Pharmacokinetics of IP2018 | Tmax | From start to end of assessment |