Safety, Tolerability, Pharmacokinetic, Including Food Interaction, and Pharmacodynamic Profile of BIA 5-1058.

NCT02151994 | Completed Phase 1 Results

• 1 other identifier: BIA-51058-101
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to to assess the safety and tolerability of BIA 5 1058 after single and multiple oral doses

Conditions

Hypertension and Chronic Heart Failure

Keywords

BIA 5-1058; hypertension; chronic heart failure; cardiovascular disorders

Outcome Measures

Primary Outcomes (3)

• Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Single Ascending Dose (SAD) Period

  Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as "mild", "moderate" or "severe" and the relationship between the AEs and the study medication was indicated as "not related", "unlikely", "possible", "probable" or ''definite".

  Just before drug administration and twice daily until 72 h after (last) drug administration

• Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Multiple Ascending Dose (MAD) Period

  Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as "mild", "moderate" or "severe" and the relationship between the AEs and the study medication was indicated as "not related", "unlikely", "possible", "probable" or ''definite".

  Just before drug administration and twice daily until 72 h after (last) drug administration

• Percentage (%) of Subjects With Treatment-Emergent Adverse Event (TEAE) Related to Study Medication (SM) - Food Effect (FE)

  Just before drug administration and twice daily until 72 h after (last) drug administration, subjects were asked non-leading questions to determine the occurrence of AEs. Subjects were asked in general terms about any AEs at regular intervals during each study period. In addition, all AEs reported spontaneously during the course of the study were recorded. All answers were assessed by the Medical Investigator (MI), coded using the Medical Dictionary for Regulatory Activities (MedDRA; Version 14.0) and recorded in the AEs Record. The intensity of the AEs was rated as "mild", "moderate" or "severe" and the relationship between the AEs and the study medication was indicated as "not related", "unlikely", "possible", "probable" or ''definite".

  Just before drug administration and twice daily until 72 h after (last) drug administration

Study Arms (2)

BIA 5-1058

EXPERIMENTAL

BIA 5-1058 (5, 25 and 100 mg) tablets

Drug: BIA 5-1058

Placebo

PLACEBO COMPARATOR

tablets, visually matching active medication

Drug: Placebo

Interventions

BIA 5-1058 DRUG

oral administration

Also known as: Zamicastat

BIA 5-1058

Placebo DRUG

oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gender - male
• Age - 18 - 55 years, inclusive
• Body Mass Index (BMI) - 18.0 - 30.0 kg m2 (BMI (kg m2) = Body weight (kg) - Heigh t2 (m 2))
• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, power drinks), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research centre until discharge
• Medical history without major pathology
• Normal resting supine blood pressure and pulse rate showing no clinically relevant deviations as judged by the MI
• Computerised (12-lead) ECG recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the MI
• All values for haematology and for clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the MI
• Willingness to sign the written ICF

You may not qualify if:

• Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, haematological, neurologic, or psychiatric disease
• An automatic ECG QTc interval reading at screening or enrolment of + 440 ms.
• Evidence of clinically relevant pathology
• Mental handicap
• History of relevant drug and or food allergies
• Smoking more than 10 cigarettes and or cigars and or pipes daily
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
• Use of any prescription drug within 30 days before study drug administration with the exception of influenza vaccination
• Use of any over-the-counter drugs including health supplements, herbal supplements such as St. John's Wort extract (except for the occasional use of acetaminophen (paracetamol), aspirin and vitamins - 100 recommended daily allowance) within 7 days before study drug administration. The use of paracetamol and or topical medication was allowed up to 3 days before entrance into the clinical research facility
• Participation in a drug study within 90 days prior to drug administration
• Participation in more than 3 other drug studies in the 10 months preceding the start of this study (this was the first administration of study drug)
• Donation of more than 50 mL of blood within 90 days prior to first drug administration
• Donation of more than 1.5 litres of blood in the 10 months preceding the start of this study (this was the first administration of study drug)
• Positive screen on drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids), barbiturates, benzodiazepines, tricyclic antidepressants and alcohol
• Intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

PRA

Zuidlaren, 9471 GP, Netherlands

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

zamicastat

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

• Title: Head of Clinical Research
• Organization: BIAL-Portela & Ca, S.A.,

clinical.trials@bial.com

(+351)-22-9866100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: June 2, 2014
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 5, 2016
• Results First Posted: January 5, 2016

Record last verified: 2015-11

Locations

NL (1)