Investigation into the Interaction between BIA 5-1058 and Furosemide
Research type
Research Study
Full title
An Open-Label, Three Period, Fixed Sequence Study to Assess the Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide in Healthy Subjects under Fasting Conditions
IRAS ID
233923
Contact name
Annelize Koch
Contact email
Sponsor organisation
BIAL
Eudract number
2017-002807-93
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
This is considered a drug drug interaction study. The test drug is called BIA 5-1058 and the other drug is called furosemide.
BIA 5-1058 is proposed to help with the treatment of pulmonary arterial hypertension (PAH). Furosemide is prescribed to treat oedemas which often form as a result of PAH. Furosemide has been available for a number of years.
In this study there are three treatment periods. At treatment period 1 the test drug will be administered by itself, at treatment period 2 the test drug and furosemide with be administered together and lastly at treatment period 3 furosemide will be given alone.
It is important that the drugs are tested together as it is very likely that both drugs will be co-administered in a clinical setting. Blood samples will be taken at various time-points in order to allow us to achieve the objectives of the study.
For this study 44 healthy male and female subjects will be recruited for 40 subjects to complete.
REC name
Wales REC 1
REC reference
17/WA/0392
Date of REC Opinion
14 Dec 2017
REC opinion
Further Information Favourable Opinion