NCT02775240

Study of SHP620 (Maribavir) in Healthy Adults

A Phase 1, Open-label, 2-period Fixed-sequence Study to Evaluate the Effect of Multiple Doses of SHP620 (Maribavir) on the Pharmacokinetics of Digoxin and Dextromethorphan in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cytomegalovirus (CMV)

Interventions

Type	Name	Description
DRUG	Digoxin	0.5 mg (2 x 0.25 mg) Digoxin oral dose
DRUG	Maribavir	200mg twice a day for 8 days
DRUG	Dextromethorphan	30 mg oral dose

Timeline

• Start date: 2016-07-21
• Primary completion: 2016-09-12
• Completion: 2016-09-12
• First posted: 2016-05-17
• Last updated: 2021-06-03
• Results posted: 2019-01-16

Locations

1 site across 1 country: United States