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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 24, 2017

Primary Completion Date

July 5, 2017

Study Completion Date

July 5, 2017

Conditions
Healthy Volunteers
Interventions
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.

Trial Locations (1)

NG11 6JS

Quotient Clinical, Ruddington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Indivior Inc.

INDUSTRY

NCT03058237 - A Phase 1 Bioavailability Study of Arbaclofen Placarbil Modified Release Formulations in Healthy Volunteers | Biotech Hunter | Biotech Hunter