Safety, Tolerability, PK, PD and efficacy of IPED2015

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Double-Blind, Placebo-Controlled, Ascending Single Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of IPED2015 in Healthy Male Subjects and Healthy Elderly Male Subjects (Part A and B). A Phase II, Randomised, Placebo-Controlled, Double-Blind, Crossover Study, Investigating the Effects of a Single Oral Dose of IPED2015 on Erectile Function in Males with Erectile Dysfunction (Part C).

• IRAS ID

  244775

• Contact name

  Peter Dewland

• Contact email

  peterdewland@macplc.com

• Sponsor organisation

  Initiator Pharma A/S

• Eudract number

  2018-001308-13

• Duration of Study in the UK

  0 years, 9 months, 28 days

• Research summary

  The study purpose is to test a drug called IPED2015, that is being developed for the treatment of erectile dysfunction (ED). ED is the term used to describe when a man is unable to develop or sustain an erection, which can lead to difficulties in having sexual intercourse. The drugs that are currently available to treat ED work by relaxing the blood vessels in the penis, so more blood can flow through the penis to produce an erection. Although these drugs are effective in treating the condition in some men, approximately 30% to 40% of them do not respond to this treatment. The study drug is a new compound which works in a different way by enhancing the effects of substances in the body such as dopamine to help stimulate an erection. The study drug is being developed in the hope that it will treat men in whom current treatments for ED do not work.
  The main aims of this study are:to assess the safety and tolerability of the study drug to see how the body absorbs and removes the study drug and to assess the effect of the study drug on the body
  This study will be divided into 3 parts (Part A, Part B, and Part C). During Part A (healthy male subjects), 48 participants will be divided into 6 groups (8 per group). During Part B (healthy elderly male subjects), 8 participants will be in 1 group only. During Part C (males with erectile dysfunction), it is planned that 12 participants will be divided into 2 groups (6 per group). This is a single site study and will be conducted in the early phase unit of MAC Clinical Research. Participation in Part A and B will last approximately 5 weeks and Participation in Part C will last approximately 6 weeks

• REC name

  Wales REC 1

• REC reference

  18/WA/0175

• Date of REC Opinion

  13 Jun 2018

• REC opinion

  Further Information Favourable Opinion