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

NCT02281422 | Completed Phase 1 Results

• 1 other identifier: BIA-2093-112
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• Cmax - Peak Plasma Concentration

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

  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.

• AUC(0-12h) - AUC From Time Zero to 12h

  BIA 2-194; BIA 2-195; Oxcarbazepine are BIA 2-093 metabolites AUC - area under the plasma concentration versus time curve

  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.

Secondary Outcomes (1)

• Tmax (hr) - Time at Which Cmax Occurred

  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.

Study Arms (5)

Group 1 normal renal function

OTHER

normal renal function (creatinine clearance \> 80 mL/min)

Drug: BIA 2-093

Group 2 mild renal impairment

OTHER

mild renal impairment (creatinine clearance 50-80 mL/min)

Drug: BIA 2-093

Group 3 moderate renal impairment

OTHER

moderate renal impairment (creatinine clearance 30-50 mL/min)

Drug: BIA 2-093

Group 4 severe renal impairment

OTHER

severe renal impairment (creatinine clearance \<30 mL/min)

Drug: BIA 2-093

Group 5 end stage renal disease

OTHER

end stage renal disease, requiring haemodialysis (ESRD)

Drug: BIA 2-093

Interventions

BIA 2-093 DRUG

Group 1 normal renal function; Group 2 mild renal impairment; Group 3 moderate renal impairment; Group 4 severe renal impairment; Group 5 end stage renal disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Farmovs-Parexel

Bloemfontein, Bloemfontein, 9301, South Africa

Location

MeSH Terms

Conditions

Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 3, 2014
• Study Start: March 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: December 31, 2014
• Results First Posted: December 31, 2014

Record last verified: 2014-12

Locations

ZA (1)