Phase 1 ADME and IV microtracer study in healthy females (QSC118021)
Research type
Research Study
Full title
An Open Label, Single-Dose, Two Part Study Designed to Assess the Mass Balance Recovery, Metabolite Profile, Metabolite Identification and Absolute Bioavailability of [14C]-Nolasiban in Healthy Female Subjects
IRAS ID
250579
Contact name
Oliver Pohl
Contact email
Sponsor organisation
ObsEva SA
Eudract number
2018-002645-10
Duration of Study in the UK
0 years, 2 months, 21 days
Research summary
The Sponsor is developing the test medicine, called Nolasiban, to increase the ongoing pregnancy rate following in vitro fertilisation (IVF), which is a technology to help women become pregnant. During IVF, an egg is removed from the woman’s ovaries and fertilised with sperm in a laboratory. The fertilised egg, called an embryo, is then returned to the woman’s womb to grow and develop.
The study will try to identify how the test medicine is taken up, broken down and removed from the body, as well as how much of the test medicine is absorbed by the body. The safety and tolerability of the study drug will also be assessed.
The study will consist of 2 parts involving up to 12 healthy female volunteers who are not able to have children. In Part 1, up to 6 volunteers will receive a dose of 900 mg of the radiolabelled study drug as a liquid to drink. The volunteers will be dosed on Day 1 and will remain in clinic until Day 11 once the discharge criteria are met. If the discharge criteria are not met by Day 11, the volunteers may remain in the clinical unit until Day 13. In Part 2, up to 6 healthy female volunteers will be enrolled and receive one dose of the test medicine as a fluid mixture of the test medicine in water, following this dose the volunteers will receive a second very small dose of the radiolabelled test medicine directly into the vein. The volunteers will be discharged on Day 4 and return on Days 5, 6 and 7 for additional blood samples.
REC name
HSC REC B
REC reference
18/NI/0179
Date of REC Opinion
16 Oct 2018
REC opinion
Favourable Opinion