HealthyPhase 1NCT00426036
Effect of Severe Renal Impairment on Pharmacokinetics and Metabolism of a Single Administration of Licarbazepine
A Phase 1 study testing Licarbazepine in people with Healthy, run by Novartis at 1 site in Czechia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Licarbazepine
- How many people
- 12 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Healthy
- Being tested
- Licarbazepine
- Keywords
- Open-label study, healthy subjects, stable impaired renal function, licarbazepine, pharmacokinetics, metabolism, safety.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LicarbazepineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigative site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426036
- Sponsor's protocol ID
- CLIC477D2311
- Status last verified
- Jun 2007
- First submitted
- 23 Jan 2007
- Last updated
- 22 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00426036
- Acronym / sponsor ID
- CLIC477D2311
- Conditions
- Healthy
- Keywords
- Open-label study, healthy subjects, stable impaired renal function, licarbazepine, pharmacokinetics, metabolism, safety.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- First posted
- 24 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Licarbazepine | Drug | – |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis principal investigator
Investigative site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Licarbazepine in people with Healthy, run by Novartis at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of severe renal impairment on pharmacokinetics of. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2007.