Ignite Creation Date:
2024-05-06 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03489005
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2018-03-29
Brief Title:
Effect of BIA 5 1058 on Cardiac Repolarization
Sponsor:
Bial - Portela C SA
Organization:
Bial - Portela C SA
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled and Open-label Active Controlled 4 Period Crossover Trial to Evaluate the Effect of BIA 5 1058 on Cardiac Repolarization in Healthy Adult Males and Females Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 subjects last assessment scheduled or unscheduled
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 subjects last assessment scheduled or unscheduled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-001682-25 | EUDRACT_NUMBER | None | None |