NCT03058237

A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

For Parts 1, 2 and 3, participants will attend the clinical unit for a screening visit up to 28 days before dosing. For each treatment period, eligible subjects will be admitted to the clinical unit on the evening before dosing (Day -1). Participants will receive each regimen in the morning of Day 1 and will remain on site until 48 h post-dose. There will be a minimum washout period of 7 days between administration of each regimen. Where interim decisions occur, the interval between periods will be sufficient to permit the decision process. Arbaclofen Placarbil MR Prototype Tablets will be administered in Part 1 and one prototype will be selected for development in Part 2 where the release rate of modified release (MR) prototype formulations will be optimised using a design space concept (at a fixed low dose). A selected MR prototype formulation from Part 2 may be administered in Part 3 at up to 4 different dose levels (low, mid-low, mid-high, high). The suggested doses in Part 3 may be modified based on emerging safety and PK data from Part 2 of the study. In Parts 2 and 3, there will be an option to dose selected Arbaclofen Placarbil MR Prototype Tablets in the fed state.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Arbaclofen Placarbil SR	One low dose oral tablet of Arbaclofen Placarbil sustained release (SR) in the fasted state.
DRUG	Arbaclofen Placarbil MR Prototype A	One low dose oral tablet pf Arbaclofen Placarbil modified release (MR) Prototype A in the fasted state; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice
DRUG	Arbaclofen Placarbil MR Prototype B	One low dose oral tablet of Arbaclofen Placarbil modified release (MR) Prototype B; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice
DRUG	Arbaclofen Placarbil IR	One low dose oral capsule of Arbaclofen Placarbil immediate release (IR) in the fasted state.

Timeline

• Start date: 2017-01-24
• Primary completion: 2017-07-05
• Completion: 2017-07-05
• First posted: 2017-02-20
• Last updated: 2018-01-17

Locations

1 site across 1 country: United Kingdom