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NCT03882762 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol
A Phase 1 study, sponsored by Tris Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT03882762 is a Phase 1 study that has completed, run by Tris Pharma. The registered enrollment target is 34 participants.
The verdict
NCT03882762, a Phase 1 study, has completed, sponsored by Tris Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the pharmacokinetics (PK), safety and tolerability profile of cebranopadol (GRT6005) in patients with varying degree of renal impairment and participants with normal renal function after an oral single dose administration. This study was a Phase 1, multi-center, non-randomized, open-label, parallel group, single-dose study in up to 24 male and female patients with varying degree of renal impairment and participants with normal renal function. Within 14 days before the administration of cebranopadol the general eligibility of the participants for the study was assessed according to the inclusion/exclusion criteria. Estimated glomerular filtration rate (eGFR) was determined according to the Modification of Diet in Renal Disease (MDRD) equation. A treatment period from Day -1 to Day 8 was performed, with participant confinement to the study site from Day -1 to Day 6 and an outpatient visit on Day 8. A single dose of cebranopadol 200 μg was administered on Day 1. Multiple blood and urine samples were drawn for pharmacokinetic evaluations and safety laboratory monitoring. Additional blood samples were taken prior investigational medicinal product (IMP) administration to assess serum creatinine concentration and protein binding. An End-of-Trial Visit was performed at the time, or within 7 days, of the final blood sample on Day 8 or at early withdrawal.
Interventions
- DRUG Cebranopadol 200 μg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-06-20 |
| Est. Completion | 2014-09-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03882762
The ClinicalTrials.gov registry entry for NCT03882762 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tris Pharma, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cebranopadol 200 μg tablet is the first listed.
NCT03882762 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03882762 about?
NCT03882762 is a clinical study titled "A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol". The objective of this study was to evaluate the pharmacokinetics (PK), safety and tolerability profile of cebranopadol (GRT6005) in patients with varying degree of renal impairment and participants with normal renal function after an oral single dose administration. This study was a Phase 1, multi-...
What is the current status of trial NCT03882762?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2013-06-20. Estimated completion is 2014-09-17.
What interventions are being tested in trial NCT03882762?
The interventions under investigation include: Cebranopadol 200 μg tablet (DRUG).
Who is sponsoring clinical trial NCT03882762?
This trial is sponsored by Tris Pharma, which has 14 total clinical trials registered on ClinicalTrials.gov.
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