Cardiovascular DiseasePhase 1NCT03489005
Effect of BIA 5 1058 on Cardiac Repolarization
A Phase 1 study testing BIA 5-1058 and Moxifloxacin 400 mg in people with Cardiovascular Disease and Pulmonary Arterial Hypertension, run by Bial - Portela C S.A. at 1 site in United Kingdom.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Pulmonary Arterial Hypertension, Heart Failure
- What is being tested?
- BIA 5-1058 and Moxifloxacin 400 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Apr 2018to 5 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18.0 and 28.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable) at Screening or Period 1 Check-in as assessed by the Investigator (or designee).
- No clinically significant abnormalities in 12-lead ECG rate, rhythm, or conduction at Screening or Period 1 Check-in.
- Females will not be pregnant (negative pregnancy test at Screening and Period 1 Check in) or lactating, and females of childbearing potential and males will agree to use contraception.
- Able to comprehend and willing to sign an ICF before any study procedure and to abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- Increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.
- History of tendonitis or tendon rupture associated with treatment with quinolone antibiotics.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- Subjects with alanine aminotransferase >1.0 × the upper limit of normal (ULN) and/or aspartate aminotransferase >1.0 × ULN and/or total bilirubin >1.0 × ULN (isolated bilirubin >1.0 × ULN and ≤1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%), as confirmed by subsequent repeat assessment, at Screening or Period 1 Check-in.
Show all 30Show fewer
- Sustained supine systolic blood pressure >140 mmHg or <90 mmHg or diastolic blood pressure >95 mmHg at Screening or baseline for Period 1 unless deemed not clinically significant by the Investigator.
- A resting ECG HR <45 bpm or >90 bpm.
- An abnormal ECG indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS interval >110 ms, QTcF <300 ms or >450 ms, or PR interval >220 ms. Any rhythm other than sinus rhythm that is interpreted by the Investigator to be clinically significant.
- History of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia) or a family history of long QT syndrome or sudden death.
- History of clinically significant alcoholism or drug/chemical abuse.
- Alcohol consumption of >28 units per week for males and >21 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test result, positive urine cotinine test, or positive urine drug screen (confirmed by repeat) at Screening or Period 1 Check-in.
- Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects whose results are compatible with prior immunization may be included at the discretion of the Investigator.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to the first dose.
- Use or intend to use any medications/products known to alter QT/QTc within 14 days or 5 half-lives (whichever is longer) prior to the first dose, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to the first dose, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any prescription medications/products including hormone replacement therapy and oral, implantable, transdermal, injectable, or intrauterine hormonal contraceptives within 14 days prior to the first dose, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any slow-release medications/products considered to still be active within 14 days prior to the first dose, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations within 7 days prior to the first dose, unless deemed acceptable by the Investigator (or designee).
- Use of tobacco- or nicotine-containing products within 3 months prior to Screening.
- Receipt of blood products within 2 months prior to Period 1 Check-in.
- Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Vegetarians, vegans, or other medical dietary restrictions.
- Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the Investigator.
- Have previously completed or withdrawn from this study or any other study investigating BIA 5 1058, and have previously received the investigational product.
- Not able to reliably communicate with the Investigator or sub-Investigator.
- Unlikely to cooperate with the requirements of the study.
- Subjects who are study site employees or immediate family members of a study site or Sponsor employee.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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 subject's last assessment (scheduled or unscheduled).
- Being tested
- BIA 5-1058, Placebo Oral Tablet, Moxifloxacin 400 mg
- Keywords
- BIA 5-1058, Pulmonary arterial hypertension, Heart failure, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Arterial Hypertension, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 5-1058Drug
Also called Zamicastat
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
Placebo Oral TabletDrug
Matching placebo tablets administered as follows:
- placebo, as 12 × 0-mg tablets
Moxifloxacin 400 mgDrug
Administered as follows:
- 400 mg moxifloxacin, as 1 × 400-mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period 1 | Other | Interventions to be administered:
Schema 1:
1. 400 mg BIA 5-1058
2. 1200 mg BIA 5-1058
3. Placebo
4. Moxifloxacin
Schema 2:
1. 1200 mg BIA 5-1058
2. Placebo
3. 400 mg BIA 5-1058
4. Moxifloxacin Receives: Drug: BIA 5-1058; Drug: Placebo Oral Tablet; Drug: Moxifloxacin 400 mg |
| Treatment Period 2 | Other | Interventions to be administered:
Schema 1
1. 1200 mg BIA 5-1058
2. Moxifloxacin
3. 400 mg BIA 5-1058
4. Placebo
Schema 2:
1. Placebo
2. Moxifloxacin
3. 1200 mg BIA 5-1058
4. 400 mg BIA 5-1058 Receives: Drug: BIA 5-1058; Drug: Placebo Oral Tablet; Drug: Moxifloxacin 400 mg |
| Treatment Period 3 | Other | Interventions to be administered:
Schema 1
1. Placebo
2. 400 mg BIA 5-1058
3. Moxifloxacin
4. 1200 mg BIA 5-1058
Schema 2
1. 400 mg BIA 5-1058
2. 1200 mg BIA 5-1058
3. Moxifloxacin
4. Placebo Receives: Drug: BIA 5-1058; Drug: Placebo Oral Tablet; Drug: Moxifloxacin 400 mg |
| Treatment Period 4 | Other | Interventions to be administered:
Schema 1
1. Moxifloxacin
2. Placebo
3. 1200 mg BIA 5-1058
4. 400 mg BIA 5-1058 Schema 2
1. Moxifloxacin 2. 400 mg BIA 5-1058 3. Placebo 4. 1200 mg BIA 5-1058 Receives: Drug: BIA 5-1058; Drug: Placebo Oral Tablet; Drug: Moxifloxacin 400 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start9 Apr 2018
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489005
- Sponsor's protocol ID
- BIA-51058-115
- Other IDs
- 2017-001682-25, 2017
- Status last verified
- Oct 2019
- First submitted
- 29 Mar 2018
- Last updated
- 31 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03489005
- Acronym / sponsor ID
- BIA-51058-115
- Keywords
- BIA 5-1058, Pulmonary arterial hypertension, Heart failure, Cardiovascular Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 subject's last assessment (scheduled or unscheduled).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Period 1 | Other | Drug: BIA 5-1058, Drug: Placebo Oral Tablet, Drug: Moxifloxacin 400 mgInterventions to be administered: Schema 1: 1. 400 mg BIA 5-1058 2. 1200 mg BIA 5-1058 3. Placebo 4. Moxifloxacin Schema 2: 1. 1200 mg BIA 5-1058 2. Placebo 3. 400 mg BIA 5-1058 4. Moxifloxacin |
| Treatment Period 2 | Other | Drug: BIA 5-1058, Drug: Placebo Oral Tablet, Drug: Moxifloxacin 400 mgInterventions to be administered: Schema 1 1. 1200 mg BIA 5-1058 2. Moxifloxacin 3. 400 mg BIA 5-1058 4. Placebo Schema 2: 1. Placebo 2. Moxifloxacin 3. 1200 mg BIA 5-1058 4. 400 mg BIA 5-1058 |
| Treatment Period 3 | Other | Drug: BIA 5-1058, Drug: Placebo Oral Tablet, Drug: Moxifloxacin 400 mgInterventions to be administered: Schema 1 1. Placebo 2. 400 mg BIA 5-1058 3. Moxifloxacin 4. 1200 mg BIA 5-1058 Schema 2 1. 400 mg BIA 5-1058 2. 1200 mg BIA 5-1058 3. Moxifloxacin 4. Placebo |
| Treatment Period 4 | Other | Drug: BIA 5-1058, Drug: Placebo Oral Tablet, Drug: Moxifloxacin 400 mgInterventions to be administered: Schema 1 1. Moxifloxacin 2. Placebo 3. 1200 mg BIA 5-1058 4. 400 mg BIA 5-1058 Schema 2 1. Moxifloxacin 2. 400 mg BIA 5-1058 3. Placebo 4. 1200 mg BIA 5-1058 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index between 18.0 and 28.0 kg/m2, inclusive.
- In good health, determined by no clinically significant findings from medical history, physical examination, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is acceptable) at Screening or Period 1 Check-in as assessed by the Investigator (or designee).
- No clinically significant abnormalities in 12-lead ECG rate, rhythm, or conduction at Screening or Period 1 Check-in.
- Females will not be pregnant (negative pregnancy test at Screening and Period 1 Check in) or lactating, and females of childbearing potential and males will agree to use contraception.
- Able to comprehend and willing to sign an ICF before any study procedure and to abide by the study restrictions.
Key exclusion criteria (30 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- Increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.
- History of tendonitis or tendon rupture associated with treatment with quinolone antibiotics.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIA 5-1058Also: ZamicastatSubjects 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 | Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4 |
| Placebo Oral TabletMatching placebo tablets administered as follows: - placebo, as 12 × 0-mg tablets | Drug | Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4 |
| Moxifloxacin 400 mgAdministered as follows: - 400 mg moxifloxacin, as 1 × 400-mg tablet | Drug | Treatment Period 1, Treatment Period 2, Treatment Period 3, Treatment Period 4 |
Primary outcome
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.
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.
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.
1 secondary outcome
QT interval corrected for heart rate based on the Fridericia correction (QTcF)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIA 5-1058 and Moxifloxacin 400 mg in people with Cardiovascular Disease and Pulmonary Arterial Hypertension, run by Bial - Portela C S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.