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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: Completed Phase 1 study, sponsored by Mylan.
NCT02578082 is a Phase 1 study that has completed, run by Mylan. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
TD-4208 Cmax derived from plasma concentration-time curves
Interventions
- DRUG TD-4208
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
What the finished NCT02578082 record still lists
NCT02578082 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which TD-4208 is the first listed.
NCT02578082 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02578082's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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