Effect of Severe Renal Impairment on Pharmacokinetics and Metabolism of a Single Administration of Licarbazepine
This study has been completed.
Information provided by:
First received: January 23, 2007
Last updated: June 21, 2007
Last verified: June 2007
This study will assess the influence of severe renal impairment on the pharmacokinetics of licarbazepine and its glucuronide conjugate after single oral administration in healthy subjects and in subjects with stable impaired renal function.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label Study in Healthy Subjects and in Patients With Stable Impaired Renal Function to Assess the Effect of Severe Renal Impairment on Licarbazepine Pharmacokinetics and Metabolism After the Single Administration of a 500 mg Licarbazepine Immediate Release (IR) Tablet
Primary Outcome Measures:
- Influence of severe renal impairment on pharmacokinetics of
- licarbazepine and its glucuronide conjugate after single oral dose of 500 mg licarbazepine IR in healthy subjects and in severe renal impaired patients.
Secondary Outcome Measures:
- Influence of severe renal impairment on pharmacokinetics of two enantiomers of licarbazepine, the glucuronide conjugates of licarbazepine and its two enantiomers after single oral dose of 500 mg licarbazepine IR in healthy subjects and i
- Safety and tolerability of single oral doses of 500 mg given as one 500 mg IR tablet in healthy subjects and in severe renal impaired patients.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male and female subjects/patients from 18-60 years of age
- Body mass index (BMI) must be within the range of 18 and 30 kg/m². Subjects/patients must weigh a minimum of 50 kg.
- Female subjects/patients must either have been surgically sterilized or hysterectomized at least 6 months prior to screening.
- Subject/patient must be able to provide written informed consent prior to study participation.
- Clinically significant abnormal laboratory values at the screening evaluation or at the baseline re-evaluation, for patients excluding those normally associated with severe degree of renal impairment or the primary cause of renal insufficiency.
- Use of any over-the-counter medications or herbal / natural supplements during 2 weeks prior to dosing. (acetaminophen is acceptable, but must be documented in the Concomitant Medications / Non-Drug Therapies page of the CRF).
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or other amount considered to compromise the health of the subject/patient if previous history of anemia exists.
- Significant acute illness within the two weeks prior to dosing.
- History of any significant cardiovascular events (M.I., angioplasty, angina) within 6 months of study start.
- A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
- History of hyponatremia.
- History of seizures.
- Any surgical or medical condition which might significantly alter the absorption,distribution, metabolism or excretion of drugs other than renal impairment or which may jeopardize the subject/patient in case of participation in the study. The investigator should be guided by history of any of the following: inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding gastropathy (gastroparesis) or enteropathy major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection clinical evidence of pancreatic injury or pancreatitis
- History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result .
- History of drug or alcohol abuse within the 6 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
Other protocol-defined inclusion/exclusion criteria may apply
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426036
|Novartis Investigative site
|Prague, Czech Republic |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 23, 2007
||June 21, 2007
||Czech Republic: State Institute for Drug Control
Keywords provided by Novartis:
Open-label study, healthy subjects, stable impaired renal function, licarbazepine, pharmacokinetics, metabolism, safety.
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 26, 2014