NCT04095286

Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open-label, randomized, single-dose, three-period cross-over study in healthy participants. The aim of this study is to provide clinically relevant information on the pharmacokinetic (PK) and safety profile of a new lower dose formulation ambrisentan (AMB) tablet, which is intended for pediatric use. The study will compare the relative bioavailability of the lower dose tablet, dispersed in water and administered orally, with the reference marketed AMB tablet in healthy adults. The total study duration for each participant is expected to be approximately 9 weeks.

Conditions

• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	AMB new formulation (1 mg)	AMB tablets will be available at a unit dose strength of 1 mg. Participants will orally administer 5 tablets of 1 mg unit dose.
DRUG	Reference AMB (5 mg)	AMB reference tablet will be available as film-coated tablet at unit dose strength of 5 mg. Participants will orally administer 1 tablet of 5 mg unit dose

Timeline

• Start date: 2019-09-30
• Primary completion: 2019-12-17
• Completion: 2019-12-17
• First posted: 2019-09-19
• Last updated: 2020-08-06
• Results posted: 2020-08-06

Locations

1 site across 1 country: United Kingdom