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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02581592
The ClinicalTrials.gov registry entry for NCT02581592 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, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (56% lower). The listed sponsor is Mylan, which has 22 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.