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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
MAC
Manchester, United Kingdom
RECRUITINGErectile Function
Rigiscan device assessment of tumescence
Time frame: A 6 hours time interval after dosing
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
Time frame: From randomisation to end of study participation
Pharmacokinetics of IP2018
AUC
Time frame: From start to end of assessments
Pharmacokinetics of IP2018
Tmax
Time frame: From start to end of assessment
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