Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

An Open-label, Single-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281422
Recruitment Status : Completed
First Posted : November 2, 2014
Results First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance

Condition or disease Intervention/treatment Phase
Epilepsy Drug: BIA 2-093 Phase 1

Detailed Description:

This was an open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance (stages of renal function according to the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products Guidelines) for the evaluation of pharmacokinetics in patients with impaired renal function.

The trial commenced with Groups 1 and 2. An interim safety evaluation was conducted and, as there were no safety concerns, the trial continued with Groups 3 and 4. After another interim safety evaluation with the data from Groups 3 and 4, the trial commenced with Group 5.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093 in Subjects With Various Degrees of Renal Impairment
Study Start Date : March 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Group 1 normal renal function
normal renal function (creatinine clearance > 80 mL/min)
Drug: BIA 2-093
Group 2 mild renal impairment
mild renal impairment (creatinine clearance 50-80 mL/min)
Drug: BIA 2-093
Group 3 moderate renal impairment
moderate renal impairment (creatinine clearance 30-50 mL/min)
Drug: BIA 2-093
Group 4 severe renal impairment
severe renal impairment (creatinine clearance <30 mL/min)
Drug: BIA 2-093
Group 5 end stage renal disease
end stage renal disease, requiring haemodialysis (ESRD)
Drug: BIA 2-093



Primary Outcome Measures :
  1. Cmax - Peak Plasma Concentration [ Time Frame: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose. ]
    BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites

  2. AUC(0-12h) - AUC From Time Zero to 12h [ Time Frame: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose. ]

    BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites

    AUC - area under the plasma concentration versus time curve



Secondary Outcome Measures :
  1. Tmax (hr) - Time at Which Cmax Occurred [ Time Frame: pre-dose and 1, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7, 9, 12, 24, 48, 72 and 96 hours post-dose. ]

    BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites

    Cmax - maximum observed plasma drug concentration




Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females at least 18 years of age, with body mass not less than 50 kg.
  • Female subjects had to be post-menopausal, surgically sterilized or using a reliable method of contraception.
  • Subjects suffering from a chronic illness, other than hepatic impairment, had to have a stable condition, regarded by the investigator as unlikely to influence the outcome of the study.
  • Renal failure, the extent of which, as measured by the creatinine clearance, resulted in recruitment to one of five renal function groups.
  • Medical records indicating a stable serum creatinine (variation of not more than 30%), for at least 3 months prior to the screening visit (Groups 2 to 4 only), as determined by the clinical investigator. The sérum creatinine had to be stable to allow for an accurate determination of the creatinine clearance and therefore allowed for correct allocation to one of the renal function groups. Subjects who were recruited into Group 1 had normal renal function.

Exclusion Criteria:

  • The receipt of any investigational drug within 30 days prior to this study.
  • Clinically significant abnormal findings (as judged by the investigator) for the following parameters, except those consistent with findings in renal failure: haematology, biochemistry, clotting profile, urinalysis, vital signs or ECG screening tests.
  • A history or laboratory evidence of hepatic impairment and/or disease. Owing to the metabolic pathway of BIA 2-093, any degree of hepatic impairment would have had a confounding effect on the PK analysis.
  • Positive test for HIV-1 or HIV-2 Antibodies, Hepatitis B surface antigen and Hepatitis C Antibodies.

HIV positive patients, and patients with Hepatitis B and C, generally have a below average, and in some cases a markedly decreased, level of health owing to the nature of the respective infections and the natural course of the diseases, both of which are often complicated by an array of opportunistic illnesses. Their ill health would have been further worsened by the fact that the patients are invarious degrees of renal failure, which has its own, often debilitating, complications. If patients with HIV or Hepatitis B or C were included in the study, this could have led to statistical confusion when assessing the safety and tolerability parameters. This is because events reported by the patients, which may be a part of the spectrum of complaints in HIV positive patients and Hepatitis B and C patients, would have confounded the safety and tolerability analysis. Furthermore, Hepatitis B and C, which may cause an element of hepatic impairment, would have confounded the PK analysis due to the metabolic pathway of BIA 2-093. In addition, by administering the study medication to these subjects, any adverse events that might have occurred would have added to the discomfort of the patient.

  • A history of any illness that, in the opinion of the Investigator and/or Sponsor, might have confounded the results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281422


Locations
Layout table for location information
South Africa
Farmovs-Parexel
Bloemfontein, South Africa, 9301
Sponsors and Collaborators
Bial - Portela C S.A.

Layout table for additonal information
Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02281422    
Other Study ID Numbers: BIA-2093-112
First Posted: November 2, 2014    Key Record Dates
Results First Posted: December 31, 2014
Last Update Posted: December 31, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action