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Effect of BIA 5 1058 on Cardiac Repolarization

NCT03489005 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2020-12-31

No results posted yet for this study

Summary

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)

Conditions

Interventions

DRUG

BIA 5-1058

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

DRUG

Placebo Oral Tablet

Matching placebo tablets administered as follows: \- placebo, as 12 × 0-mg tablets

DRUG

Moxifloxacin 400 mg

Administered as follows: \- 400 mg moxifloxacin, as 1 × 400-mg tablet

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Bial - Portela C S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2018-10-05
Completion
2018-10-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489005 on ClinicalTrials.gov