CYP induction study OBE2109 vs CYP3A4 substrate & food effect
Research type
Research Study
Full title
An open-label single sequence, cross-over drug-drug interaction study, investigating the effect of OBE2109 on the pharmacokinetics of CYP3A4 substrate (midazolam) and the effect of food on the pharmacokinetics of OBE2109.
IRAS ID
212932
Contact name
Anna Parzybut
Contact email
Sponsor organisation
ObsEva SA
Eudract number
2016-003068-37
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
This is an open-label single sequence, cross-over study to investigate the effect of OBE2109 on the pharmacokinetics of a single oral dose of a substrate midazolam and the effect of food on the pharmacokinetics of the study drug in healthy women of child bearing potential. OBE2109 is being developed for the potential treatment of endometriosis and uterine fibroids.\n\n24 healthy female volunteers aged 18-55 years will be enrolled. \n\nThe study will comprise a 13-day treatment period incorporating 7 nights and 7 outpatient visits.\n\nThe 7 nights will be split into, 3 nights at stage 1, and 2 nights at stages 2 and 3. On Day -2 each volunteer will attend for baseline safety tests. Check-in to the study centre will be on Day -1.\n\nStage 1:. \nDay 1: Volunteers will receive a single oral dose of midazolam \nDay 2: Volunteers will receive a single oral dose of the study drug after breakfast. They will be discharged on Day 3 after safety assessments and PK blood sampling.\n\nStage 2: \nDay 5: Return to the study centre for 2 nights. \nDay 6: After a 4- day wash-out period, volunteers will receive daily oral doses of the study drug, fasted for 7 days. \n\nDay 7: Volunteers will be discharged and return daily for PK blood sampling and (fasted) study drug administration until Day 12.\n\nDays 8 to 12 will be outpatient visits.\n\nStage 3: \nDay 12: Volunteers will check in to the study unit for 2 nights. \nDay 13: Volunteers will receive a single oral dose of midazolam and an oral dose of the study drug in a fasted state. Volunteers will be discharged on Day 14, after safety assessments and PK blood sampling.\n\nSafety assessments including vital signs will be performed pre-dose and at specified time points post dose.\n\nDay 20 will be a post study physical examination.\nThe total duration will be up to 42 days (including the screening period). \n\n\n
REC name
HSC REC A
REC reference
16/NI/0160
Date of REC Opinion
2 Sep 2016
REC opinion
Further Information Favourable Opinion