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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: Completed Phase 1 study of Impaired Hepatic Function, sponsored by Tetraphase Pharmaceuticals.
NCT02135302 is a Phase 1 study of Impaired Hepatic Function that has completed, run by Tetraphase Pharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with mild, moderate, and severe impaired hepatic function compared with normal healthy subjects
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 |
What the finished NCT02135302 record still lists
NCT02135302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT02135302's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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