The purpose is to evaluate the effect of single therapeutic (400 mg) and supratherapeutic (1200 mg) doses of BIA 5-1058 on the time-matched change from baseline in placebo-adjusted interval corrected (QT) for heart rate (HR)
This will be a Phase 1, randomized, double-blind, placebo-controlled and open-label, active controlled, 4 period, crossover study in healthy male and female subjects under fed conditions. The study will be double blinded for BIA 5-1058 and placebo and open label for moxifloxacin. The central ECG laboratory and ECG readers will be blinded to study treatment sequence, timepoint, and subject. All subjects will receive each of the following 4 treatments: * 400 mg BIA 5 1058 * 1200 mg BIA 5 1058 * placebo * 400 mg moxifloxacin Potential subjects will be screened to assess their eligibility to enter the study between 28 and 3 days prior to the first treatment administration. For each treatment period, subjects will be admitted into the Clinical Research Unit (CRU) on Day 2 and be confined to the CRU until Discharge on Day 4. Each subject will receive a single dose of study medication on Day 1 of each treatment period. There will be a washout of at least 10 days between doses, and subjects will return to the CRU for a Follow-up visit 14 ± 2 days after Period 4 Discharge. The total duration of study participation for each subject from Screening through Follow-up visit) is anticipated to be approximately 80 days. The start of the study is defined as the date the first enrolled subject signs an Informed Consent Form (ICF). The point of enrollment occurs at the time of subject number allocation. The end of the study is defined as the date of the last subject's last assessment (scheduled or unscheduled).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
49
Subjects will receive BIA 5-1058 tablets (containing 100 mg) as single, oral doses 30 minutes after the start of a moderate mealas follows: * 400 mg BIA 5 1058, as 4 × 100 mg tablets and 8 placebo tablets * 1200 mg BIA 5 1058, as 12 × 100 mg tablets
Matching placebo tablets administered as follows: \- placebo, as 12 × 0-mg tablets
Administered as follows: \- 400 mg moxifloxacin, as 1 × 400-mg tablet
Covance Clinical Research Unit Ltd.
Leeds, United Kingdom
time-matched change from baseline in placebo-adjusted QT interval corrected for heart rate based on an individual correction method after BIA 5-1058 dosing.
In each treatment period, continuous 12-lead digital ECG recording will be performed by Holter monitor for at least 24 hours prior to dose until approximately 24 hours postdose.
Time frame: Day 1 at -1.25, -1, and -0.75 hours predose, Day -1 (baseline) at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 23 hours postdose.
QT interval corrected for heart rate based on the Fridericia correction (QTcF)
In each treatment period, continuous 12-lead digital ECG recording will be performed by Holter monitor for at least 24 hours prior to dose until approximately 24 hours postdose.
Time frame: Day 1 at -1.25, -1, and -0.75 hours predose, Day -1 (baseline) at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 23 hours postdose.
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