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NCT02578082 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment
A Phase 1 study, sponsored by Mylan.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02578082 is a Phase 1 study that has completed, run by Mylan. The registered enrollment target is 16 participants.
The verdict
NCT02578082, a Phase 1 study, has completed, sponsored by Mylan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal renal function or severe (eGFR \<30 mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the pharmacokinetics (PK) of TD 4208.
Interventions
- DRUG TD-4208
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02578082
The ClinicalTrials.gov registry entry for NCT02578082 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TD-4208 is the first listed.
NCT02578082 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02578082 about?
NCT02578082 is a clinical study titled "Pharmacokinetics of TD-4208 in Patients With Severe Renal Impairment". This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal renal function or severe (eGFR \<30 mL/min/1.73 m2) renal impairment to evaluate the effect of renal impairment on the pharmacokinetics (PK) of TD 4208.
What is the current status of trial NCT02578082?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-12. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02578082?
The interventions under investigation include: TD-4208 (DRUG).
Who is sponsoring clinical trial NCT02578082?
This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.
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