Renal Impairment
Conditions
Keywords
Renal Impairment
Brief summary
The purpose of this study is to assess the single dose pharmacokinetics (PK) and safety of TR701 FA in subjects with advance renal impairment.
Detailed description
To assess the pharmacokinetics (PK) and evaluate the safety of intravenous (IV) infusion of TR-701 free acid (FA) in subjects with advanced renal impairment compared with matched control subjects with normal renal function
Interventions
DRUGTR-701 FA single infusion
Single IV infusion, 200 mg daily for 7 days
DRUGTR-701 FA
Two separate infusions of 200 mg
Sponsors
Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* BMI between 18.0 and 40.0 kg/m2 inclusive * Male or female subjects between 18 and 75 years of age * Stable dosage of medication for 30 days * for dialysis patients, receiving chronic and stable maintenance hemodialysis for at least 3 months
Exclusion criteria
* Functioning transplanted solid organ * High tyramine diet * Significant, unstable, or life-threatening condition or organ or system condition or disease, other than kidney disease in renal subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite (or Profile) of Pharmacokinetics | predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 hours post-dose | Cmax, Area Under Curve, Tmax t1/2 will be compared between each renal group and the control group, including calculation of geometric mean ratio and corresponding 90% confidence intervals. |
Countries
United States
Outcome results
None listed