A Single Dose Intravenous ADME Study in Healthy Volunteers (QSC202874)
Research type
Research Study
Full title
A Single-Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-Vazegepant (BHV-3500) in Healthy Male Subjects After Intravenous Dosing
IRAS ID
279969
Contact name
Mary Donohue
Contact email
Sponsor organisation
Biohaven Pharmaceuticals, Inc.
Eudract number
2020-000735-41
Duration of Study in the UK
0 years, 1 months, 12 days
Research summary
The Sponsor is developing the test medicine, vazegepant, for the potential treatment of migraines. Migraines are a type of headache that usually affects one side of the head and can be accompanied by nausea (feeling sick) and sensitivity to light or sound.\n\nThis study will try to identify how the test medicine is taken up, broken down and removed from the body when given into the vein as an infusion. Metabolites (break down products of the test medicine) will also be identified. In this study, the test medicine is radiolabelled with carbon-14. Radiolabelled means that the test medicine has a radioactive component (carbon-14) that helps to track where the test medicine is in the body. The safety and tolerability of the test medicine will also be tested.\n\nThis is a Phase 1, single centre, one part study involving up to 6 healthy male volunteers. Volunteers will be admitted to the clinic on the morning of Day -1 and will be fasted overnight. On the morning of Day 1, volunteers will receive a single 5 mg dose of the test medicine as an intravenous infusion (arm injection into a vein) over 15 minutes.\n\nIt is planned that volunteers will be discharged as a group 10 days after they have received the test medicine (Day 11). However, if the criteria has not been met by this planned time, their stay may be extended by a maximum of 48 hours (Day 13). If the criterion is still not met by Day 13, or if additional residency is not considered appropriate or necessary, then home collections of urine and/or faeces may be requested at the discretion of the investigator. \n\nThe total time volunteers will be involved in this study is expected to be approximately up to 6 weeks from the screening visit until the end of the study.
REC name
HSC REC A
REC reference
20/NI/0055
Date of REC Opinion
15 May 2020
REC opinion
Further Information Favourable Opinion