BAY1002670 Radiolabelled Mass Balance,Metabolism and Excretion Pattern
Research type
Research Study
Full title
Additional single center, open-label, non-randomized, non-placebo-controlled study to investigate the metabolism, excretion pattern, mass balance, safety, tolerability and pharmacokinetics of BAY 1002670 after single dose oral administration of 5 mg [14C]-BAY 1002670 in healthy postmenopausal females
IRAS ID
130000
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Bayer HealthCare
Eudract number
2013-000707-16
ISRCTN Number
N/A
Research summary
BAY 1002670 is being developed as a long-term treatment of symptomatic uterine leiomyomas. Uterine leiomyomas (also called fibroids or myomas) are common benign tumors of the myometrium (muscle layer of the uterus), which are reported to occur in approximately 30-40% of all women of reproductive age.
The study drug will be administered under fasting conditions in the morning of Day 0. Immediately after oral intake of the BAY 1002670 solution, volunteers should drink approximately 220 ml of water.
Subjects will stay at the clinic from one day before scheduled drug administration until at least 14 days after drug administration (336 hours post administration). Subjects may be required to remain in the unit for up to a further 3 days until Day 17 (408 hours post administration) in case the recovery requirements are not met by day 14.
The cumulative recovery of radioactivity needs to exceed 90% of the administered dose and the recovery of radioactivity in urine + feces has to be less than 1% of the administered dose for 2 consecutive days. If subjects still do not meet both recovery requirements by Day 17, they will be invited to attend for a further 4 outpatient visits on Day 18, 19, 20 & 21, providing 24 h urine and fecal collections at each visit.
The total duration of the study for each subject from signing Informed Consent to last visit will be approximately 9 weeks. Up to 6 subjects may be dosed to ensure to end up with 4 evaluable subjects for the complete treatment.REC name
North East - York Research Ethics Committee
REC reference
13/NE/0143
Date of REC Opinion
5 Jun 2013
REC opinion
Further Information Favourable Opinion