Comparing bioavailability of different AL-794 formulations; version 1
Research type
Research Study
Full title
A randomised, open-label, single-dose, 3-way crossover study to evaluate the relative bioavailability of the existing AL-794 formulation with concept formulations, and the effect of food, in healthy subjects. (HMR: 17-020).
IRAS ID
228377
Contact name
Adeep Puri
Contact email
Sponsor organisation
Alios BioPharma
Eudract number
2018-000437-12
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (AL-794) is an experimental medicine for treating influenza (‘flu’). We hope that the study medicine will work by blocking a substance that the flu virus uses to multiply itself. The study medicine works differently compared to existing flu treatments in that it could be combined with current flu medicines and may make them more effective, so we hope it may treat more types of flu.
We’re doing this study, in healthy people, to compare an existing tablet form with 3 new tablet forms of the study medicine. We’ll also test whether food affects blood levels of the study medicine when it’s taken as a new tablet form.
To do that, we’ll enrol 36 healthy participants, aged 18–60, in 3 groups of 12 volunteers. Each participant will have 3 study sessions. In each session they’ll take a single dose of the study medicine: once in the previously tested tablet form after breakfast, once in a new tablet form after breakfast, and once in a new tablet form after an overnight fast.
Participants will take up to 7 weeks to finish the study. They’ll make up to 6 outpatient visits and stay on the ward for up to 6 nights in total.
A pharmaceutical company (Alios Biopharma) is funding the study.
The study will take place at 1 centre in London.
REC name
Scotland A: Adults with Incapacity only
REC reference
18/SS/0017
Date of REC Opinion
30 Mar 2018
REC opinion
Favourable Opinion