A PK and Safety Study in Subjects With Hepatic Impairment
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 5/21/2016 |
| Start Date: | August 2011 |
| End Date: | May 2012 |
A Phase 1 Open-Label Study With Oral TR-701 FA to Assess Pharmacokinetics and Safety in Subjects With Moderate or Severe Hepatic Impairment
Assess the single dose PK and safety of TR701 FA in subjects with Moderate or Severe hepatic
impairment versus matched control subjects with normal hepatic function.
impairment versus matched control subjects with normal hepatic function.
This study will assess the single-dose pharmacokinetics (PK) and safety of TR-701 free acid
(FA) in subjects with Moderate or Severe hepatic impairment compared with matched control
subjects with normal hepatic function.
(FA) in subjects with Moderate or Severe hepatic impairment compared with matched control
subjects with normal hepatic function.
Inclusion Criteria:
- Moderate or severe hepatic impairment or matched control
- BMI between 18.0 and 40.0 kg/m2
Exclusion Criteria:
- Evidence of acute deterioration of hepatic function within 8 weeks
- ALT or AST ≥ 5 times upper limit of normal for moderates; ALT or AST ≥ 8 times upper
limit of normal for severes
- Total bilirubin > 5 mg/dl for moderates; no upper limit for severes
- Hemoglobin < 10g/dl for moderates; Hemoglobin < 9g/dl for severes
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