HypertensionPhase 1NCT02845037
Tolerability, Pharmacokinetics and Dopamine ß-hydroxylase (DßH) Inhibition Profile of BIA 5-453
A Phase 1 study testing BIA 5-453 in people with Hypertension and Chronic Heart Failure, run by Bial - Portela C S.A. at 1 site in France.
Trial summary
The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single oral doses Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Chronic Heart Failure
- What is being tested?
- BIA 5-453
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- May 2007to Sep 2007
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A signed and dated informed consent form before any study-specific screening procedure was performed.
- Aged between 18 and 45 years, inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must have been able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
Who cannot join
- Medical History
- Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
- History of any clinically important drug allergy.
Show all 15Show fewer
- Physical and Laboratory Findings
- An automatic ECG QTc interval reading at screening or enrolment >450 ms.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
- Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).
- Prohibited treatments
- Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
- Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 72 before study day -1.
- Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
- Donation of blood (ie 450 ml) within 90 days before study day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Rising Single Oral Dose Study to Investigate the Tolerability, Pharmacokinetics and Dopamine ß-hydroxylase (DßH) Inhibition Profile of BIA 5-453 in Healthy Male Volunteers
The purpose of this study is to assess the safety and tolerability of BIA 5-453 after single oral doses
Read the detailed description
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in 10 sequential groups of 8 healthy young male volunteers. Within each group (n=8), 6 volunteers were randomised to receive BIA 5-453 and the remaining 2 volunteers were randomised to receive placebo. A volunteer participated only in a single period.
- Conditions
- Hypertension, Chronic Heart Failure
- Being tested
- BIA 5-453, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIA 5-453Drug
Also called Etamicastat
BIA 5-453 Gelatine capsule for oral administration (1, 10 or 20 mg). Single oral doses of BIA 4-543 2 mg, 10 mg, 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg were administered to subjects in fasting conditions.
PlaceboDrug
Also called Placebo Gelatine capsule
Placebo Gelatine capsule for oral administration. The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient (API).
| Study group | Role | What they receive |
|---|---|---|
| 2 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 10 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 20 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 50 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 100 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 200 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 400 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 600 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 900 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
| 1200 mg or placebo | Experimental | BIA 5-453 or placebo Receives: Drug: BIA 5-453; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
Measured: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Time to reach Cmax (Tmax)
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
Measured: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-t)
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
Measured: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Area under the plasma concentration-time curve from time 0 to the infinity (AUC0-∞)
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
Measured: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
% of subjects with at least one adverse event
Adverse events were continuously monitored from screening until the follow-up visit.
Measured: through study completion, an average of 72 hours
% of subjects by dose group with at least one treatment-emergent adverse event (TEAEs)
Treatment emergent adverse events (TEAE) were defined as adverse events which did not exist before dosing and appeared in the 72 hours following treatment administration or which was present before administration and worsened in the 72 hours following treatment administration.
Measured: through study completion, an average of 72 hours
Apparent terminal elimination half-life (t1/2)
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
Measured: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startMay 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bial - Portela C S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845037
- Sponsor's protocol ID
- BIA-5453-101
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rising Single Oral Dose Study to Investigate the Tolerability, Pharmacokinetics and Dopamine ß-hydroxylase (DßH) Inhibition Profile of BIA 5-453 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02845037
- Acronym / sponsor ID
- BIA-5453-101
- Conditions
- Hypertension, Chronic Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bial - Portela C S.A.Industry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Jul 2016 (estimated)
- 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 of this study is to assess the safety and tolerability of BIA 5-453 after single oral doses
Detailed description
Single centre, randomised, double-blind, placebo-controlled study of single ascending doses in 10 sequential groups of 8 healthy young male volunteers. Within each group (n=8), 6 volunteers were randomised to receive BIA 5-453 and the remaining 2 volunteers were randomised to receive placebo. A volunteer participated only in a single period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 2 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 10 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 20 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 50 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 100 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 200 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 400 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 600 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 900 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
| 1200 mg or placebo | Experimental | Drug: BIA 5-453, Drug: PlaceboBIA 5-453 or placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A signed and dated informed consent form before any study-specific screening procedure was performed.
- Aged between 18 and 45 years, inclusive.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must have been able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
Key exclusion criteria (15 listed)
- Medical History
- Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
- Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g
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 5-453Also: EtamicastatBIA 5-453 Gelatine capsule for oral administration (1, 10 or 20 mg). Single oral doses of BIA 4-543 2 mg, 10 mg, 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg were administered to subjects in fasting conditions. | Drug | 10 mg or placebo, 100 mg or placebo, 1200 mg or placebo, 2 mg or placebo, 20 mg or placebo, 200 mg or placebo, 400 mg or placebo, 50 mg or placebo, 600 mg or placebo, 900 mg or placebo |
| PlaceboAlso: Placebo Gelatine capsulePlacebo Gelatine capsule for oral administration. The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient (API). | Drug | 10 mg or placebo, 100 mg or placebo, 1200 mg or placebo, 2 mg or placebo, 20 mg or placebo, 200 mg or placebo, 400 mg or placebo, 50 mg or placebo, 600 mg or placebo, 900 mg or placebo |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
Time to reach Cmax (Tmax)
Time frame: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC0-t)
Time frame: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
Area under the plasma concentration-time curve from time 0 to the infinity (AUC0-∞)
Time frame: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
% of subjects with at least one adverse event
Time frame: through study completion, an average of 72 hours
Adverse events were continuously monitored from screening until the follow-up visit.
% of subjects by dose group with at least one treatment-emergent adverse event (TEAEs)
Time frame: through study completion, an average of 72 hours
Treatment emergent adverse events (TEAE) were defined as adverse events which did not exist before dosing and appeared in the 72 hours following treatment administration or which was present before administration and worsened in the 72 hours following treatment administration.
Apparent terminal elimination half-life (t1/2)
Time frame: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose
Mean BIA 5-453 plasma pharmacokinetic parameters ± SD following single doses of 2, 10, 20, 50, 100, 200, 400, 600, 900 and 1200 mg of BIA 5-453 in 10 groups of 6 healthy volunteers each
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 26 Jul 2016.
- 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 5-453 in people with Hypertension and Chronic Heart Failure, run by Bial - Portela C S.A. at 1 site in France.
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 15 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 26 Jul 2016. 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 France. 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?
Maximum observed plasma concentration (Cmax) (time frame: Day 1 pre-dose then at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 60, and 72 hours post-dose). The study lists 7 primary outcomes in all. 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 26 Jul 2016.