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Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840565
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.

Tracking Information
First Submitted Date  ICMJE July 19, 2016
First Posted Date  ICMJE July 21, 2016
Last Update Posted Date July 21, 2016
Study Start Date  ICMJE September 2007
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2016)
  • Percent of subjects with at least one adverse event [ Time Frame: through study completion, an average of 10 days ]
  • Percent of subjects by dose group with at least one treatment-emergent adverse event (TEAEs) [ Time Frame: through study completion, an average of 10 days ]
    Treatment-emergent adverse events are adverse events that occurred either in the 72 hours after dosing or that was present prior to dosing but exacerbated within 72 hours after dosing.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453
Official Title  ICMJE A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 in Healthy Male Volunteers
Brief Summary The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.
Detailed Description

Two centres, double-blind, randomised, placebo-controlled study of six dosage regimens of BIA 5-453 in six groups of healthy male subjects.

In each group, the study consisted of a 10-day multiple-dose period. Progression to the next dose level only occurred if the previous dose level was considered to be safe and well tolerated. An appropriate interval separated the investigation of doses to permit a timely review and evaluation of safety data (including plasma exploratory pharmacokinetics) prior to proceeding to a higher dose level.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Chronic Heart Failure
Intervention  ICMJE
  • Drug: BIA 5-453
    Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
    Other Name: Etamicastat
  • Drug: Placebo
    The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
Study Arms  ICMJE
  • Experimental: BIA 5-453 25 mg or placebo
    Multiple oral doses of BIA 5-453 25 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
    Interventions:
    • Drug: BIA 5-453
    • Drug: Placebo
  • Experimental: BIA 5-453 50 mg or placebo
    Multiple oral doses of BIA 5-453 50 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
    Interventions:
    • Drug: BIA 5-453
    • Drug: Placebo
  • Experimental: BIA 5-453 100 mg or placebo
    Multiple oral doses of BIA 5-453 100 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
    Interventions:
    • Drug: BIA 5-453
    • Drug: Placebo
  • Experimental: BIA 5-453 200 mg or placebo
    Multiple oral doses of BIA 5-453 200 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
    Interventions:
    • Drug: BIA 5-453
    • Drug: Placebo
  • Experimental: BIA 5-453 400 mg or placebo
    Multiple oral doses of BIA 5-453 400 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
    Interventions:
    • Drug: BIA 5-453
    • Drug: Placebo
  • Experimental: BIA 5-453 600 mg or placebo
    Multiple oral doses of BIA 5-453 600 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
    Interventions:
    • Drug: BIA 5-453
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2016)
57
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A signed and dated informed consent form before any study-specific screening procedure was performed.
  2. Aged between 18 and 45 years, inclusive.
  3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
  4. 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.
  5. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

Medical History

  1. 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.
  2. Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study Day1.
  3. History of drug abuse within 1 year before study Day1.
  4. History of alcoholism within 1 year before Day1. 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
  5. History of any clinically important drug allergy.

    Physical and Laboratory Findings

  6. An automatic ECG QTc interval reading at screening or enrolment >450 ms.
  7. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
  8. Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).

    Prohibited treatments

  9. Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
  10. 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.
  11. 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.
  12. Donation of blood (ie 450 ml) within 90 days before study Day1.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02840565
Other Study ID Numbers  ICMJE BIA-5453-102
2007-004142-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Bial - Portela C S.A.
Study Sponsor  ICMJE Bial - Portela C S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bial - Portela C S.A.
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP