The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT02172742
First received: June 23, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

The purpose of this study is to investigate the effects of multiple-dose administration of BIA 2-093 on the steady-state pharmacokinetics of digoxin in healthy subjects.


Condition Intervention Phase
Epilepsy
Drug: BIA 2-093
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Maximum steady-state plasma concentration (Cmax) [ Time Frame: Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • time of occurrence of Cmax (tmax) at steady-state [ Time Frame: Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose ] [ Designated as safety issue: No ]
  • steady-state area under the plasma concentration-time profile over 24 h (AUCτ) [ Time Frame: Day 6 and Day 7: pre-dose; Day 8: pre-dose, ½, 1, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: May 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIA 2-093 1200 mg once-daily
The 1200 mg dose of BIA 2-093 consisted of 2 tablets strength 600 mg; oral route.
Drug: BIA 2-093

According to randomisation, in each period subjects were dosed with a once-daily dose of digoxin of 0.50 mg on Days 1 and 2, and 0.25 mg of digoxin on Days 3 to 8, concomitantly with either a dose of 1200 mg of BIA 2-093 or placebo, orally, with 200 mL of potable water. The dosing was to occur between 07:00 and 09:00 am.

The BIA 2-093 mg dose consisted of 2 tablets of 600 mg. The 0.5 mg loading dose of digoxin consisted of 2 tablets of Lanoxin™ 0.25 mg.

Drug: Placebo

According to randomisation, in each period subjects were dosed with a once-daily dose of digoxin of 0.50 mg on Days 1 and 2, and 0.25 mg of digoxin on Days 3 to 8, concomitantly with either a dose of 1200 mg of BIA 2-093 or placebo, orally, with 200 mL of potable water. The dosing was to occur between 07:00 and 09:00 am.

The BIA 2-093 mg dose consisted of 2 tablets of 600 mg. The 0.5 mg loading dose of digoxin consisted of 2 tablets of Lanoxin™ 0.25 mg.

Placebo Comparator: Placebo
The Placebo dose consisted of 2 tablets matching BIA 2-093 600 mg tablets; oral route
Drug: BIA 2-093

According to randomisation, in each period subjects were dosed with a once-daily dose of digoxin of 0.50 mg on Days 1 and 2, and 0.25 mg of digoxin on Days 3 to 8, concomitantly with either a dose of 1200 mg of BIA 2-093 or placebo, orally, with 200 mL of potable water. The dosing was to occur between 07:00 and 09:00 am.

The BIA 2-093 mg dose consisted of 2 tablets of 600 mg. The 0.5 mg loading dose of digoxin consisted of 2 tablets of Lanoxin™ 0.25 mg.

Drug: Placebo

According to randomisation, in each period subjects were dosed with a once-daily dose of digoxin of 0.50 mg on Days 1 and 2, and 0.25 mg of digoxin on Days 3 to 8, concomitantly with either a dose of 1200 mg of BIA 2-093 or placebo, orally, with 200 mL of potable water. The dosing was to occur between 07:00 and 09:00 am.

The BIA 2-093 mg dose consisted of 2 tablets of 600 mg. The 0.5 mg loading dose of digoxin consisted of 2 tablets of Lanoxin™ 0.25 mg.


Detailed Description:

Single centre, multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover study in 12 healthy volunteers. The study consisted of two 8-day treatment periods separated by a washout of 10 or more days. During each of the treatment periods the volunteers received either a daily oral dose of BIA 2-093 1200 mg once-daily (od) or matching placebo, concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female subjects aged between 18 and 45 years, inclusive.
  • Subjects of body mass index (BMI) between 19 and 28 kg/m2, inclusive.
  • Subjects who were healthy as determined by pre-study medical history, physical examination, neurological examination, and 12-lead ECG.
  • Subjects who had clinical laboratory tests clinically acceptable.
  • Subjects who were negative for HBs Ag, anti-HCV Ab and anti-HIV-1 and HIV-2 Ab tests at screening.
  • Subjects who were negative for alcohol and drugs of abuse at screening.
  • Subjects who were non-smokers or who smoked less than 10 cigarettes or equivalent per day.
  • Subjects who were able and willing to give written informed consent.
  • In case of female volunteers, subjects who were not of childbearing potential by reason of surgery or, if of childbearing potential, used one of the following methods of contraception: double-barrier or intrauterine device.
  • In case of female volunteers, subjects who had a negative pregnancy test at screening.

Exclusion Criteria:

  • Subjects who did not conform to the above inclusion criteria.
  • Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
  • Subjects who had a clinically relevant surgical history.
  • Subjects who had a clinically relevant family history.
  • Subjects who had a history of relevant atopy.
  • Subjects who had a history of relevant drug hypersensitivity.
  • Subjects who had a history of alcoholism or drug abuse.
  • Subjects who consumed more than 14 units of alcohol a week.
  • Subjects who had any of the following findings on the ECG: QTc interval >440 msec; first-, second- or third-degree atrioventricular block; atrial fibrillation; heart rate below 50 bpm; any other relevant abnormality.
  • Subjects who had a significant infection or known inflammatory process on screening and/or admission.
  • Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhoea, heartburn).
  • Subjects who had used prescription drugs within 4 weeks of first dosing.
  • Subjects who had used over the counter medication excluding oral routine vitamins but including mega dose vitamin therapy within one week of first dosing.
  • Subjects who had used any investigational drug and/or participated in any clinical trial within 2 months of their first admission.
  • Subjects who had previously received BIA 2-093.
  • Subjects who had donated and/or received any blood or blood products within the previous 2 months prior to screening.
  • Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
  • Subjects who could not communicate reliably with the investigator.
  • Subjects who were unlikely to co-operate with the requirements of the study.
  • Subjects who were unwilling or unable to give written informed consent.
  • In case of female volunteers, subjects who were pregnant or breast-feeding.
  • In case of female volunteers, subjects who were of childbearing potential and did not use an authorized effective contraceptive method.
  Contacts and Locations
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: NCT02172742

Locations
Portugal
Human Pharmacology Unit (UFH)Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA,
Mamede do Coronado, Portugal
Sponsors and Collaborators
Bial - Portela C S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT02172742     History of Changes
Other Study ID Numbers: BIA-2093-107
Study First Received: June 23, 2014
Last Updated: June 23, 2014
Health Authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IP

Keywords provided by Bial - Portela C S.A.:
Eslicarbazepine acetate
BIA 2-093

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Digoxin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014