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NCT02135302 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With Impaired Hepatic Function and Healthy Subjects
A Phase 1 study of Impaired Hepatic Function, sponsored by Tetraphase Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 3
- Study locations
NCT02135302 is a Phase 1 study of Impaired Hepatic Function that has completed, run by Tetraphase Pharmaceuticals. The registered enrollment target is 24 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT02135302, a Phase 1 study of Impaired Hepatic Function, has completed, sponsored by Tetraphase Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (± 2 days) after initiation of study drug administration. Approximately 24 subjects will be enrolled: 18 subjects with impaired hepatic function (6 subjects who meet the criteria for each of the 3 Child-Pugh categories of mild \[5 - 6 points\], moderate \[7 - 9 points\], and severe \[10 - 15 points\]) and 6 healthy subjects without hepatic impairment. Healthy subjects will be matched to hepatically impaired subjects in gender, age, and body mass index (BMI). All subjects will be administered a single IV dose of eravacycline (1.5 mg/kg).
Conditions Studied
Interventions
- DRUG eravacycline
Study Locations (3)
Colorado
- Davita Clinical Research - Lakewood
Florida
- Orlando Clinical Research Center - Orlando
Tennessee
- New Orleans Center for Clinical Research - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02135302
The ClinicalTrials.gov registry entry for NCT02135302 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tetraphase Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Impaired Hepatic Function appearing as the primary indexed condition, and to 1 intervention - of which eravacycline is the first listed.
NCT02135302 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Colorado, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT02135302 about?
NCT02135302 is a clinical study titled "A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With Impaired Hepatic Function and Healthy Subjects". This is a multi-center, open-label clinical study to assess the single-dose PK of eravacycline in subjects with hepatic impairment and healthy subjects conducted at approximately 3 sites in the United States. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End ...
What is the current status of trial NCT02135302?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2013-10. Estimated completion is 2014-03.
What conditions does trial NCT02135302 study?
This clinical trial studies the following conditions: Impaired Hepatic Function.
What interventions are being tested in trial NCT02135302?
The interventions under investigation include: eravacycline (DRUG).
Who is sponsoring clinical trial NCT02135302?
This trial is sponsored by Tetraphase Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02135302 being conducted?
This trial has 3 study locations across Colorado, Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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