| Trial ID: | L0805 |
| Source ID: | NCT02135276
|
| Associated Drug: |
Eravacycline
|
| Title: |
A Phase 1, Open-Label Study to Assess the Single-Dose Pharmacokinetics of Eravacycline in Subjects With End Stage Renal Disease and Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End Stage Renal Disease
|
| Interventions: |
DRUG: eravacycline
|
| Outcome Measures: |
Primary: Assess the pharmacokinetic (PK) profile of eravacycline after administration of a single intravenous (IV) dose (1.5 mg/kg) to subjects with end stage renal disease (ESRD) compared with normal healthy subjects, 5 days | Secondary: Determine the safety and tolerability of eravacycline after administration of a single IV dose (1.5 mg/kg) in subjects with ESRD compared with normal healthy subjects, 5 days
|
| Sponsor/Collaborators: |
Sponsor: Tetraphase Pharmaceuticals, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
12
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2013-12
|
| Completion Date: |
2014-05
|
| Results First Posted: |
|
| Last Update Posted: |
2021-12-17
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT02135276
|
