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NCT02767128 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers
A Phase 1 study of Iron-refractory, Iron-deficiency Anemia (IRIDA), sponsored by Rockwell Medical Technologies.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02767128: Completed Phase 1 study of Iron-refractory, Iron-deficiency Anemia (IRIDA), sponsored by Rockwell Medical Technologies.
NCT02767128 is a Phase 1 study of Iron-refractory, Iron-deficiency Anemia (IRIDA) that has completed, run by Rockwell Medical Technologies. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02767128, a Phase 1 study of Iron-refractory, Iron-deficiency Anemia (IRIDA), has completed, sponsored by Rockwell Medical Technologies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.
Primary Outcome
The outcome will be measured by assessing the Cmax of total iron with multiple different oral iron treatment. The following oral iron dosing treatments will be measured: Treatment A (Fer-in-Sol 3 mg iron/kg), Treatment B (Shohl's solution followed after 10 minutes by Fer-In-Sol, 3 mg/kg), Treatment C (Triferic 3 mg iron/kg), Treatment D (Shohl's solution followed after 10 minutes by Triferic 3 mg/kg), Treatment E (Shohl's solution followed immediately by Triferic 3 mg/kg), Treatment F (Triferic
Conditions Studied
Interventions
- DRUG Triferic
- DRUG Fer-In-Sol
- DRUG Shohl's solution
Study Locations (1)
Michigan
- Jasper Clinic - Kalamazoo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT02767128 record still lists
NCT02767128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Iron-refractory, Iron-deficiency Anemia (IRIDA) appearing as the primary indexed condition, and to 3 interventions - of which Triferic is the first listed.
NCT02767128 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02767128 about?
NCT02767128 is a clinical study titled "Pharmacokinetics and Absolute Bioavailability of Fer-In-Sol and Triferic Administered Orally With Shohl's Solution in Healthy Volunteers". The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered orally in healthy adult volunteers. It is a randomized multiple treatments, single dose study.
What is the current status of trial NCT02767128?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-04. Estimated completion is 2016-04.
What conditions does trial NCT02767128 study?
This clinical trial studies the following conditions: Iron-refractory, Iron-deficiency Anemia (IRIDA).
What interventions are being tested in trial NCT02767128?
The interventions under investigation include: Triferic (DRUG), Fer-In-Sol (DRUG), Shohl's solution (DRUG).
Who is sponsoring clinical trial NCT02767128?
This trial is sponsored by Rockwell Medical Technologies, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02767128 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02767128's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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