A drug interaction study of AL-794, v1
Research type
Research Study
Full title
A Phase-1, Open-label, Four Group, Fixed-Sequence Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir, JNJ-63623872, and Probes for P-glycoprotein, CYP3A and OATP1B1 in Healthy Volunteers (HMR code: 16-007)
IRAS ID
204073
Contact name
Adeep Puri
Contact email
Sponsor organisation
Alios BioPharma
Eudract number
2016-000391-25
Clinicaltrials.gov Identifier
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 to make them more effective, so we hope it will treat more types of flu.
We’ll check whether the study medicine affects breakdown of certain medicines, or how long it takes the body to get rid of certain medicines.
We’ll test side effects, blood levels, and effects of the study medicine when taken alone and when combined with up to 5 other medicines.
We’ll enroll up to 64 healthy volunteers, aged 18-60, in 4 groups of 16 volunteers each. Volunteers will take the study medicine twice a day, by mouth, for 7 days. Each group will also take 1 or 2 test medicines, as follows.
Group 1: Tamiflu twice a day for the first 7 days, then with study medicine for another 7days.
Group 2: JNJ-63623872 (experimental medicine) twice a day for the first 7 days, then with study medicine for another 7 days.
Groups 3 and 4: a single dose, by mouth, of midazolam and digoxin (Group 3) or pitavastatin (Group 4) at 3 different times; once on Day 1 and once on the first day (Day11) and last day (Day17) of dosing with study medicine.
Participants will take up to 8 weeks to finish the study. They’ll make 2 outpatient visits and stay on the ward for up to 18 nights in total.
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/0070
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion