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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IP2018_dose 1 | Experimental | IP2018_dose1 |
|
| IP2018_dose 2 | Experimental | IP2018_dose2 |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IP2018 | Drug | Test drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Function | Rigiscan device assessment of tumescence | A 6 hours time interval after dosing |
| 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 |
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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.
Male patients with a diagnosis of mild to moderate depression and erectile dysfunction
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claus Olesen, PhD | Contact | 61260035 | ceo@initiatorpharma.com | |
| Mikael Thomsen, PhD | Contact | 23276134 | mt@initiatorpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Fiore Fiore, MD | MAC UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MAC | Recruiting | Manchester | United Kingdom |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Drug |
Placebo |
|
AUC |
| From start to end of assessments |
| Pharmacokinetics of IP2018 | Tmax | From start to end of assessment |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |