ONO-7684 - first doses in humans
Research type
Research Study
Full title
A first-in-human, randomised, placebo-controlled, double-blind, single and multiple dose study to explore the safety, tolerability, PK and PD of oral doses of ONO-7684 in healthy subjects under fed and fasted conditions
IRAS ID
256387
Contact name
Jeremy Dennison
Contact email
Sponsor organisation
Ono Pharmaceutical Co. Ltd.
Eudract number
2018-003160-32
Duration of Study in the UK
1 years, months, days
Research summary
The study medicine is an experimental treatment for ******. ****Consider adding some info about the indication**** We hope that the study medicine will ******.\n\nEXAMPLES\n\nWe’ll test repeated doses of the study medicine, to find out its side effects, blood levels and effects on the acidity of stomach juices. We’ll also study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.\n\nWe’ll give healthy volunteers single doses of the study medicine. It’s never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. We aim to find out its side effects and blood levels, to compare tablet and liquid forms, and to study how genes (pieces of DNA) affect the way the body responds to or handles it. We’ll also test whether food affects blood levels of the study medicine.\n\nWe’ll give N healthy men, aged 18–N years, N daily doses. We’ll start with a low dose, and increase the dose as the study progresses.\n\nParticipants will take up to N weeks to finish the study. They’ll make up to N outpatient visits, and stay on the ward for N nights.\n\nA pharmaceutical company (*****) is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
18/NI/0225
Date of REC Opinion
21 Dec 2018
REC opinion
Favourable Opinion