Pharmacokinetics of Tasimelteon Alone and in Combination With a CYP3A4 Inhibitor, Ketoconazole, or a CYP3A4 Inducer, Rifampin.

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Healthy
Interventions
DRUG

tasimelteon

20mg, oral capsule, once, Days 1 and 12

DRUG

tasimelteon

20mg, oral capsule, once, Days 1 and 6

DRUG

Rifampin

600mg, oral capsules (2 x 300mg), once daily (QD), Days 2-11

DRUG

Ketoconazole

400mg, oral tablets (2 x 200mg), once daily (QD), Days 2-6

Trial Locations (1)

65802

QPS Bio-Kinetic Clinical Applications, Springfield

Sponsors
All Listed Sponsors
lead

Vanda Pharmaceuticals

INDUSTRY