PK/PD Study - Effect of OBE2109 and Concurrent or Delayed Add-Back on
Research type
Research Study
Full title
A Phase 1, Randomized, Open-Label, Parallel-Group, Pharmacokinetic/Pharmacodynamic Study Investigating the Effect of OBE2109 and Concurrent or Delayed Add-Back Therapy Administration on Bleeding Pattern of Healthy Adult Female Subjects
IRAS ID
237767
Contact name
Fiona McNeilly
Contact email
Eudract number
2017-003822-34
Duration of Study in the UK
0 years, 7 months, 0 days
Research summary
This is a Phase 1 study in healthy female volunteers. A total of 32 females aged 18 to 48 will be enrolled. The study drug, OBE2109 is being developed for the treatment of endometriosis and uterine fibroids.\nThe study purpose is to assess the effect of the study drug in combination with HRT on vaginal bleeding pattern and blood levels of female hormones, E2 and progesterone (P). In addition, study will assess the safety and tolerability of daily oral doses of OBE2109 when administered with concurrent or delayed HRT in study participants.\nThe study drug OBE2109 blocks the production of estradiol. Low estradiol levels are associated with endometriosis and uterine fibroids symptom relief, but excessive estradiol reduction may lead to side-effects. We may “add-back” in low levels of estradiol with another drug, HRT.\nScreening will take place over a 28-day period prior to a run-in period of 15 days. Each volunteer will be taking norethisterone 5mg tablets 3 times a day for 10 days in order to synchronise menstrual cycle prior to receiving study medication. On Day 1, following confirmed withdrawal bleeding and study eligibility, subjects will be randomised to receive multiple oral doses of OBE2109 administered once daily for 70 consecutive days with multiple oral doses of HRT co-administered from either Day 1 or Day 29.\nSubjects will record their bleeding pattern and treatment administration times on a daily basis in the paper diary and will report it to the clinical staff during a daily phone call throughout the study. \n
REC name
HSC REC A
REC reference
17/NI/0224
Date of REC Opinion
4 Dec 2017
REC opinion
Favourable Opinion