The effect of itraconazole dosing on the PK of the Study Drug
Research type
Research Study
Full title
An open-label study to evaluate the effect of repeated oral administration of 200 mg itraconazole (ITZ) given once daily over 14 days on the single oral dose pharmacokinetics of vilaprisan (BAY 1002670) as well as assessment of absolute bioavailability using a single i.v. microtracer dose of [14C]vilaprisan in healthy postmenopausal women
IRAS ID
174503
Contact name
Jim Bush
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2014-004929-41
Duration of Study in the UK
0 years, 3 months, 11 days
Research summary
Vilaprisan (BAY 1002670) is an investigational medication to treat women with uterine fibroids and endometriosis. Fibroids are non-cancerous tumours that grow in or around the womb (uterus). Endometriosis is a condition where tissue that behaves like the lining of the womb is found outside the womb. Endometriosis causes painful or heavy periods.
14 healthy postmenopausal women will be included in this study. This is an open-label (i.e. volunteers and study staff will know the medication and dose being used for each volunteer) study.Volunteers will receive two single oral doses of 4 mg vilaprisan administered without the co-medication of itraconazole (Period 1) and with the co-medication of Itraconazole (Period 2). Itraconazole (ITZ) is a well-known marketed drug and is classified in this study as a non-investigational medicinal product.
In addition, the first 7 volunteers will also receive a single intravenous (through the vein) dose of [14C] vilaprisan (radiolabelled) in Period 1. Radiolabelled means that a radioactive substance (Carbon 14) will be incorporated into the Study Drug to allow us to trace the 2 different administrations of Study Drug. This intravenous dose will be given 1.5 to 2 hours after administration of the oral dose.
Volunteers will enter the study site in the evening before day 0 (Study Drug administration day) in both Period 1 and Period 2 and stay for a total of 2 nights on each occasion.
The total duration of the study from screening to follow-up will be up to approximately 14 weeks per volunteer.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0071
Date of REC Opinion
20 Mar 2015
REC opinion
Further Information Favourable Opinion