At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Digoxin +2 moredrug
Likely dose
Digoxin 0.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Digoxin, Maribavir, and 1 other intervention for Cytomegalovirus (CMV). Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus (CMV)
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartJul 2016
Primary CompletionSep 2016
TodayJul 2026
First PostedMay 17, 2016
Enrollment StartJul 21, 2016
Primary CompletionSep 12, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.1 years ago
Interventions
Digoxindrug
0.5 mg (2 x 0.25 mg) Digoxin oral dose
Maribavirdrug
200mg twice a day for 8 days
Dextromethorphandrug
30 mg oral dose