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HealthyPhase 1NCT00424671

Effect of Moderate Hepatic Impairment on the Pharmacokinetics and Metabolism of a Single Dose of Licarbazepine

A Phase 1 study testing Licarbazepine in people with Healthy, run by Novartis at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess the influence of moderate hepatic impairment on the pharmacokinetics of licarbazepine after single oral administration in healthy subjects and in subjects with stable impaired hepatic function. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Licarbazepine
How many people
16 participants
Where
1 siteCzechia
Study dates
Nov 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Control group and hepatically impaired groups:
  • Male and/or female subjects between 18 and 65 years of age. Female subjects must be surgically sterilized or postmenopausal (Postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion. Menopause will be confirmed by a plasma FSH level of >40 IU/L. Female subjects must have been surgically sterilized at least 6 months prior to screening. Surgical sterilization procedures must be supported with clinical documentation made available to sponsor and noted in the Relevant Medical History / Current Medical Conditions section of the CRF)
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study. The subjects must be able to provide written informed consent prior to study participation, thus excluding subjects with encephalopathy grade 3 or 4.
  • Body mass index (BMI) must be within the range of 18 to 32. For instructions and tables see Appendix 5.
  • Hepatically impaired group:
  • Subjects must have liver cirrhosis (hepatic fibrosis with evidence of either micro- or macro-nodular regeneration) confirmed by imaging techniques, ultrasound, MRI or CT.
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  • Subjects must have physical signs consistent with a clinical diagnosis of liver cirrhosis (e.g., liver firmness to palpation, splenic enlargement, spider angiomata, palmar erythema, parotid hypertrophy, testicular atrophy, gynecomastia).
  • Subjects must have a Child-Pugh Clinical Assessment Score between 7 and 9 at both screening and baseline.
  • Vital signs (after 3 minutes resting in a supine position) which are within the following ranges: oral body temperature between 35.0-37.5 °C systolic blood pressure, 100-180 mm Hg diastolic blood pressure, 60-115 mm Hg pulse rate, 60 - 100 bpm
  • Subjects with creatinine clearance greater than 50 mL/min (based on Cockcroft and Gault formula)
  • Control group:
  • Subjects must be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
  • Subjects should be matched to the hepatically impaired group in gender, age (±10%), smoking status, BMI (±10%).
  • At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least three (3) minutes, and again when required after three (3) minutes in the standing position. Vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C systolic blood pressure, 90-140 mm Hg diastolic blood pressure, 50-90 mm Hg pulse rate, 40 - 90 bpm When blood pressure and pulse will be taken again after 3 minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 10 mm Hg drop in diastolic blood pressure and increase in heart rate (>20 bpm) associated with clinical manifestation of postural hypotension. All blood pressure measurements at other time-points should be assessed with the subject supine, unless stated otherwise in the protocol design, and utilizing the same arm for each determination.

Who cannot join

  • Control group and hepatically impaired group:
  • Participation in any clinical investigation with experimental drug therapy within four weeks prior to dosing or longer as required by local regulation.
  • Donation or loss of 400 mL or more of blood within two months prior to dosing.
  • Significant acute, new onset illness (ie, flu, gastroenteritis) within two weeks prior to dosi4. A past medical history or clinically significant ECG abnormalities or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome.
  • History of hyponatremia or seizures.
  • History of autonomic dysfunction.
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  • Subjects with a consistent, abnormally low total lymphocyte count (< 10% of total white blood cell counts)
  • A known hypersensitivity to the drug.
  • History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
  • Evidence of active alcohol or drug abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
  • Smokers who report cigarette use of more than 20 cigarettes per day. Urine cotinine levels will be measured during screening.
  • Hepatically impaired group:
  • Subjects with a history of unstable, severe, or clinically significant cardiovascular disease
  • Polymorphonuclears <1000/µL or platelets <100'000/µL at inclusion.
  • Subjects with clinically significant abnormal findings, not consistent with underlying disease, upon physical examination, ECG or laboratory evaluation.
  • Subjects with frank symptoms of encephalopathy or ataxia.
  • A recent history of acute or chronic bronchospastic disease, including asthma and chronic obstructive pulmonary disease, treated or not treated.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, or excretion of any drug.
  • Current drug treatment with other mood stabilizers, psychotropic drugs and antiepileptics.
  • Patients must be willing and able to forgo treatment with restricted medications throughout the study. Approved prescription medications will be allowed during the course of the study on a case by case basis only if the patient has been on a standard treatment regimen for at least 3 months and will continue their regular regimen without change throughout the study (unless required by protocol or to treat an adverse event) Treatments in table 5.1 are allowed in the hepatically impaired group only.
  • Control group
  • Use of any prescription medication within 1 month prior to dosing.
  • Use of over-the-counter medications or vitamins during 14 days prior to dosing (Paracetamol, aspirin or ibuprofen are acceptable, but must be documented in the CRF).
  • History or presence of liver disease or liver injury as indicated by an abnormal liver function profile such as SGOT, SGPT, GGT, alkaline phosphate, or serum bilirubin.
  • Hepatitis B as indicated by positive HBs Ag or positive anti-HBc IgM result, or Hepatitis C as indicated by positive anti-HCV result.
  • History of acute or chronic bronchospastic disease, including asthma and chronic obstructive pulmonary disease, treated or not treated.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, or excretion of any drug. The investigator should be guided by evidence of any of the following: History of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding, chronic diarrhoea; History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; History of pancreatic injury or pancreatitis; indications of impaired pancreatic function/injury as indicated by abnormal lipase or amylase; History or presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria); History of urinary obstruction or difficulty in voiding polymorphonuclears <1000/µL or platelets <100'000/µL at inclusion.
  • Known history of autoimmune disease such as SLE Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Czechia1 site

  • Novartis Investigative site

    Prague

Other trials in Czechia

About this study

Official title: An Open-Label Study in Healthy Subjects and in Subjects With Stable Impaired Hepatic Function to Assess the Effect of Moderate Hepatic Impairment on Licarbazepine Pharmacokinetics and Metabolism After a Single Dose of 1000 mg Licarbazepine IR Tablets

This study will assess the influence of moderate hepatic impairment on the pharmacokinetics of licarbazepine after single oral administration in healthy subjects and in subjects with stable impaired hepatic function.

Conditions
Healthy
Being tested
Licarbazepine

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.

  1. Influence of moderate hepatic impairment on the pharmacokinetics of

  2. licarbazepine after single oral administration of 1000 mg licarbazepine (given as 2 x 500

  3. mg IR tablets) in healthy subjects and in moderate hepatic impaired subjects

Secondary outcomes (5)

  1. Influence of moderate hepatic impairment on the pharmacokinetics of the two enantiomers of licarbazepine and the glucuronide conjugates of licarbazepine and its

  2. two enantiomers after single oral administration of 1000 mg licarbazepine (given as 2 x

  3. 500 mg IR tablets) in healthy subjects and in moderate hepatic impaired subjects

  4. Safety and tolerability of single oral doses of 1000 mg licarbazepine (given

  5. as 2 x 500 mg IR tablets) in healthy subjects and in moderate hepatic impaired subjects

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2007 (estimated)
  2. Study startNov 2006

Resources

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
16 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424671
Sponsor's protocol ID
CLIC477D2310
Status last verified
Jun 2007
First submitted
18 Jan 2007
Last updated
22 Jun 2007
Results posted
No

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 14 inclusion and 28 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 moderate hepatic impairment on the pharmacokinetics of. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424671.

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.

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