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NCT02054572 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT02054572: Completed Phase 1 study, sponsored by Amgen.
NCT02054572 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02054572, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
The total radioactivity in excreta (urine and feces) or dialysate and dialysis membrane is expressed as a percentage of the total radioactive \[¹⁴C\] administered (dose). Total radioactive counts in dialysate, dialyzer, feces, and urine were determined by accelerator mass spectrometry (AMS). Radioactivity excreted during non-sampled days was estimated by interpolation and extrapolation of the measured data.
Interventions
- DRUG [¹⁴C]Etelcalcetide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2014-02-07 |
| Est. Completion | 2014-08-15 |
| Phase | Phase 1 |
What the finished NCT02054572 record still lists
NCT02054572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which [¹⁴C]Etelcalcetide is the first listed.
NCT02054572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02054572 about?
NCT02054572 is a clinical study titled "Pharmacokinetics and Excretion of [¹⁴C]Etelcalcetide (AMG 416) in Patients With End Stage Renal Disease (ESRD) Receiving Dialysis". 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.
What is the current status of trial NCT02054572?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2014-02-07. Estimated completion is 2014-08-15.
What interventions are being tested in trial NCT02054572?
The interventions under investigation include: [¹⁴C]Etelcalcetide (DRUG).
Who is sponsoring clinical trial NCT02054572?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02054572's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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