Phase 4
Completed N=30
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
Healthy Subjects · Renal Impairments
Source: ClinicalTrials.gov NCT01491113 ↗
Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Jan 2014
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D — 21.9357; 15.5334; 10.7767; 9.1754 µg/mL
Summary
This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of impaired renal function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D |
21.9357; 15.5334; 10.7767; 9.1754 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D |
165.9996; 247.6430; 169.3392; 212.1193 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D |
0.3620; 0.7503; 0.5674; 1.0640 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D |
5.8607; 22.5573; 18.6675; 57.7773 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period |
18.6810 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E |
462.4883 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period |
8.8435 | — |
| PRIMARY Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E |
230.4393 | — |
| SECONDARY Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D |
304.7321; 247.6562; 98.7182; 74.3761 | — |
| SECONDARY Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D |
60.9464; 49.5312; 39.4873; 29.7504 | — |
| SECONDARY Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D |
1.8622; 0.9820; 0.5671; 0.3417 | — |
| SECONDARY Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D |
2.9359; 1.9826; 1.4362; 1.1484 | — |
| SECONDARY Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D |
1.0712; 0.9873; 0.8636; 0.7848 | — |
| SECONDARY Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D |
83.5936; 169.3395; 93.1346; 100.7489 | — |
| SECONDARY Renal Clearance (CLR) of Ucb L057 for Groups A to D |
14.6937; 6.8015; 4.6828; 1.6475 | — |
| SECONDARY Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period |
0.629 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D |
0.500; 1.000; 0.500; 0.500 | — |
| SECONDARY Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D |
170.3045; 252.1923; 174.0764; 217.6854 | — |
| SECONDARY Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D |
7.6164; 12.6214; 15.5033; 19.7320 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D |
5.000; 8.000; 12.000; 24.000 | — |
| SECONDARY Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D |
8.176; 32.401; 27.441; 63.126 | — |
| SECONDARY Terminal Half-life (t1/2) of Ucb L057 for Groups A to D |
12.351; 19.030; 20.303; 26.769 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period |
0.720 | — |
| SECONDARY Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E |
794.588 | — |
| SECONDARY Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period |
34.669 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period |
44.020 | — |
| SECONDARY Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E |
113.9665 | — |
| SECONDARY Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E |
1.3271 | — |
| SECONDARY Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E |
115.3702 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy subjects with normal renal function
- Subject is Japanese
- Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis
Exclusion Criteria
- Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments
Data sourced from ClinicalTrials.gov (NCT01491113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.