Drug Interaction Study between BCT197 and Azithromycin®
Research type
Research Study
Full title
An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197 exposure in healthy male subjects.
IRAS ID
211182
Contact name
William Moore
Contact email
Sponsor organisation
Mereo BioPharma 1 Ltd
Eudract number
2016-002779-84
Duration of Study in the UK
0 years, 1 months, 7 days
Research summary
This is an open-label, single-sequence study to determine if there are any contraindications with the study drug when taken with an antibiotic commonly used for the treatment of COPD.
Each volunteer will participate in a screening visit and 2 in-house periods.
Period 1 – All volunteers will receive a single dose of the study drug in a fasting state.Period 2 – All volunteers will receive 3 daily doses of the antibiotic and a single dose of the study drug in a fasting state.
For period 1, volunteers will be admitted to the unit on the evening before dosing with the study drug (Day -1) and will be discharged on the morning of Day 3, 48 hours after dosing (3 overnight stays). During period 1 volunteers will make 4 outpatient return visits for pharmacokinetic and safety blood sampling (to Day 8).
For period 2 volunteers will be admitted to the unit on Day -2 evening (Day -1 prior to dosing with the antibiotic) and they will be discharged from the unit on the morning of Day 3 (48 hours after dosing with the study drug – 4 overnight stays). After period 2 volunteers will make 5 outpatient return visits for pharmacokinetic and safety blood sampling (to Day 15).
Study drug dosing in both periods will be separated by a washout period of at least 14 days. The study duration for each volunteer will be approximately 37 days excluding the screening period. There will be a follow-up phone call 21 days after Day 1 of study period 2.
REC name
HSC REC B
REC reference
16/NI/0146
Date of REC Opinion
18 Aug 2016
REC opinion
Favourable Opinion