At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 42 enrolled
Drug / intervention
MK-3866drug
Likely dose
MK-3866 200 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 2-Part, Open-Label Trial to Evaluate the Pharmacokinetics of MK-3866 Following the Administration of a Single IV Dose to Subjects With Mild, Moderate, and Severe Renal Impairment and End Stage Renal Disease
In Brief
A Phase 1 clinical trial evaluating MK-3866 for Renal Impairment. Completed, enrolled 42 participants across 2 sites.
Detailed Summary
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the plasma by hemodialysis (HD), and evaluate the safety and tolerability of MK-3866 in participants with impaired renal function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Impairment
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionJan 2018
Study CompletionFeb 2018
TodayJul 2026
First PostedAug 23, 2017
Enrollment StartSep 1, 2017
Primary CompletionJan 28, 2018
Study CompletionFeb 9, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.9 years ago
Interventions
MK-3866drug
Single IV infusion of 200 mg administered over 30 minutes (±5 minutes) on Day 1 of each treatment period.