At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
[¹⁴C]Etelcalcetidedrug
Likely dose
[¹⁴C]Etelcalcetide 10 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.
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of [¹⁴C]AMG 416 in Patients With End Stage Renal Disease Receiving Dialysis
In Brief
A Phase 1 clinical trial evaluating [¹⁴C]Etelcalcetide for Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of \[¹⁴C\]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole blood and plasma over time.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartFeb 2014
Primary CompletionApr 2014
Study CompletionAug 2014
TodayJul 2026
First PostedFeb 4, 2014
Enrollment StartFeb 7, 2014
Primary CompletionApr 15, 2014
Study CompletionAug 15, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.4 years ago
Interventions
[¹⁴C]Etelcalcetidedrug
750 nCi of \[¹⁴C\]etelcalcetide formulated as a single 10 mg dose of etelcaletide in 2 mL liquid solution for bolus intravenous (IV) administration at the end of hemodialysis.