Conditions: Cytomegalovirus (CMV)
Keywords: Maribavir
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine how an investigational treatment (maribavir) is handled by the body when administered with two already approved drugs (digoxin and dextromethorphan). The study will also look at the safety and tolerability when maribavir is coadministered with digoxin and dextromethorphan versus digoxin and dextromethorphan alone.

Detailed description:

Arms:
arm 1: On Day 1, subjects will receive a single 0.5 mg (2 x 0.25 mg) oral dose of digoxin. arm 2: On Day 8 through Day 15, subjects will receive a 400 mg (2 x 200 mg) BID oral dose of maribavir. Subjects will be given the second dose of maribavir approximately 12 hours after the first dose. On Day 13, subjects will receive a coadministration of a single 0.5 mg (2 x 0.25 mg) oral dose of digoxin and a single 30 mg oral dose of dextromethorphan given with the morning dose of maribavir. arm 3: On Day 1, subjects will receive a single 30 mg oral dose of dextromethorphan.

Interventions: intervention 1: Digoxin intervention 2: Maribavir intervention 3: Dextromethorphan
Intervention descriptions: intervention 1: 0.5 mg (2 x 0.25 mg) Digoxin oral dose intervention 2: 200mg twice a day for 8 days intervention 3: 30 mg oral dose

Protocol document: