A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers
Status:
Completed
Trial end date:
2017-07-05
Target enrollment:
Participant gender:
Summary
Part 1
- To evaluate the pharmacokinetic (PK) profile of Arbaclofen Placarbil (AP) and R-baclofen
following dosing of Arbaclofen Placarbil Modified Release (MR) Prototype A Tablet and
Arbaclofen Placarbil MR Prototype B Tablet in healthy subjects
- To determine the relative bioavailability of AP and R-baclofen following dosing of
Arbaclofen Placarbil MR Prototype A Tablet and Arbaclofen Placarbil MR Prototype B
Tablet compared to the reference Arbaclofen Placarbil Sustained Release (SR) Tablets
(low dose)
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing
of the selected MR prototype formulation(s) in the presence of beverage
- To provide additional information on the safety and tolerability of single doses of AP
Part 2
- To evaluate the PK profile of AP and R-baclofen following dosing of Arbaclofen Placarbil
MR Prototype Tablets in healthy subjects
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing
of Arbaclofen Placarbil MR Prototype Tablets compared to the reference Arbaclofen
Placarbil Immediate Release (IR) Capsule
- To provide additional information on the safety and tolerability of single doses of AP
- To determine the relative bioavailability and PK of AP and R-baclofen following dosing
of a selected MR prototype formulation in the fed state (optional)
- To explore a possible in vitro in vivo correlation/relationship (IVIVC/IVIVR) for the
Arbaclofen Placarbil MR Prototype Tablet Formulations
Part 3
- To determine the relative bioavailability of the selected Arbaclofen Placarbil MR
Prototype Tablet in the presence of either beverage or food and/or
- To evaluate the PK profile (dose proportionality) of AP and R-baclofen following dosing
of the selected Arbaclofen Placarbil MR Prototype A + B Tablet at different dose levels
in healthy subjects
- To provide additional information on the safety and tolerability of single doses of AP