Bioavailability study of marketed and lower dose ambrisentan
Research type
Research Study
Full title
An open-label, randomized three period cross-over relative bioavailability study to compare the pharmacokinetic parameters of a lower dose formulation of ambrisentan (GSK1325760) with marketed ambrisentan in healthy adult participants.
IRAS ID
268420
Contact name
Stephanie Igwe
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2019-001699-12
Duration of Study in the UK
0 years, 6 months, 25 days
Research summary
Ambrisentan, a medicine made by GlaxoSmithKline (GSK), is approved for use under the trade name of Volibris in adults with pulmonary arterial hypertension (PAH). PAH is a rare disease caused by changes to the blood vessels that carry blood between the heart and lungs. The blood vessel walls thicken, narrowing the space for blood to flow through. This makes it harder for blood to flow, increasing blood pressure and strain on the heart. If untreated, PAH can cause heart failure and premature death. Ambrisentan treats PAH by relaxing muscles in the blood vessel wall and opening up space to allow blood to flow through.
Children also suffer from PAH, but ambrisentan is available only in tablets, which younger patients might find difficult to swallow. This study is testing a new type of tablet intended to treat children in the future. This study, in healthy adults, will compare the new type of tablet (taken swallowed whole as well as dissolved in water) with the marketed adult tablet (taken swallowed whole only). The aim of the study is to answer the following questions:
• How does the rate and amount of drug released into the blood compare between the marketed adult tablet and the new type of tablet, taken swallowed whole and/or dissolved in drinking water?
• Are the side effects the same for the marketed adult tablet and the new type of tablet?
• How does the new type of tablet taste, smell and feel when dissolved in drinking water?
The study will be conducted in approximately 24 healthy participants, and the total study duration for each participant is expected to be about 9 weeks.
The study is sponsored by GSK and will be conducted in a Medicines and Health Care Products Regulatory Agency (MHRA) accredited clinical research unit in the UK.REC name
HSC REC B
REC reference
19/NI/0157
Date of REC Opinion
27 Aug 2019
REC opinion
Further Information Favourable Opinion