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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02172742
• Date of registration: 23/06/2014
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin
• Scientific title: The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin in Healthy Volunteers
• Date of first enrolment: May 2002
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02172742
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Portugal

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: BIA 2-093

Drug: Digoxin

Drug: Placebo

Primary Outcome(s)

Cmax - Maximum Steady-state Plasma Concentration [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]

Secondary Outcome(s)

Tmax - Time of Occurrence of Cmax 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]

AUCt - Steady-state Area Under the Plasma Concentration-time Profile Over 24 h [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]

Secondary ID(s)

BIA-2093-107

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/12/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02172742