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NCT02581592 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment
A Phase 1 study of Hepatic Impairment, sponsored by Mylan.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02581592: Completed Phase 1 study of Hepatic Impairment, sponsored by Mylan.
NCT02581592 is a Phase 1 study of Hepatic Impairment that has completed, run by Mylan. The registered enrollment target is 16 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581592, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Mylan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of TD-4208.
Primary Outcome
TD-4208 Cmax, derived from plasma concentration-time curves
Conditions Studied
Interventions
- DRUG TD-4208
Study Locations (1)
Florida
- Orlando Clinical Research Center (OCRD) - Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
What the finished NCT02581592 record still lists
NCT02581592 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 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (56% lower).
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which TD-4208 is the first listed.
NCT02581592 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02581592 about?
NCT02581592 is a clinical study titled "Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment". This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of TD-4208.
What is the current status of trial NCT02581592?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2015-11. Estimated completion is 2016-04.
What conditions does trial NCT02581592 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT02581592?
The interventions under investigation include: TD-4208 (DRUG).
Who is sponsoring clinical trial NCT02581592?
This trial is sponsored by Mylan, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02581592 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02581592's enrollment target sits among peer trials
16 46th of 48 higher than 1 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment 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.
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