Comparing blood levels after taking liquid and tablet forms of AL-794
Research type
Research Study
Full title
A Phase 1, Single-Center, Randomized, Open-Label, Single-Dose, Crossover Study to Assess the Pharmacokinetics, Including Food Effect, of AL-794 Formulations in Healthy Subjects (16-014)
IRAS ID
206267
Contact name
Adeep Puri
Contact email
Sponsor organisation
Alios BioPharma
Eudract number
2016-001543-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 25 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 to make them more effective, so we hope it will treat more types of flu.
We’ll compare an existing liquid form and a new tablet form of the study medicine. We’ll also test whether food affects blood levels of the study medicine when it’s taken as a tablet. To do that, we’ll give up to 15 healthy volunteers, aged 18–60 years, 3 single doses of the study medicine: once in liquid form after an overnight fast, once in tablet form after an overnight fast, and once in tablet form after breakfast.
Depending on the results, we might test other forms of the study medicine in up to 30 healthy volunteers, aged 18–60 years.
Participants will take up to 5 weeks to finish the study. They’ll make up to 2 outpatient visits and stay on the ward for 10 nights.
A pharmaceutical company (Alios BioPharma) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
16/NI/0074
Date of REC Opinion
17 May 2016
REC opinion
Favourable Opinion