Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT01532115
First received: January 23, 2012
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the effect of BIA 9-1067 on the cardiac repolarization in adult healthy men and women volunteers.


Condition Intervention Phase
Parkinson Disease
Drug: BIA 9-1067
Drug: Placebo
Drug: moxifloxacin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Number and percentage of subjects with ECG abnormalities [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    Through standard 12-lead ECGs assess the effect BIA 9-1067 on heart rate(HR),These ECGs were centrally reviewed. Cardiac effects were assessed through an evaluation of QT, QTc (QTcI, QTcB, and QTcF), PR, QRS interval duration, HR, and morphological changes.


Secondary Outcome Measures:
  • Number of participants with Adverse Events [ Time Frame: 56 days ] [ Designated as safety issue: Yes ]
    assessment of safety and tolerability


Enrollment: 64
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIA 9-1067 Drug: BIA 9-1067
50 mg and 800 mg of BIA 9-1067 (single-dose)
Placebo Comparator: Placebo Drug: Placebo
single-dose
Active Comparator: moxifloxacin Drug: moxifloxacin
400 mg moxifloxacin (single-dose)

Detailed Description:

Single-centre, randomized, double-blind, placebo-controlled and open-label active-controlled, 4-period crossover trial in healthy male and female subjects

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A signed and dated informed consent form before any study-specific screening procedure was performed,
  • Healthy male or female 18 to 55 years of age. Women had to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation or bilateral oophorectomy at least 6 months prior to enrollment); using an intrauterine device; a non-hormonal double barrier contraceptive method (i.e., diaphragm or spermicide plus male condom) for the duration of the trial and with a negative pregnancy test at screening and upon each check-in to the study facility,
  • Had a BMI within the range of 18-30 kg/m2,
  • Able to communicate effectively with the study personnel,
  • Had no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on admission to the clinic,
  • Had a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction,
  • Non-smokers or ex-smokers for at least 3 months,
  • Adequately informed of the nature and risks of the study and gave written informed consent prior to study entry.

Exclusion Criteria:

  • Known hypersensitivity or allergy to moxifloxacin, BIA 9-1067 or related compounds such as tolcapone or entacapone,
  • Women who were pregnant or breastfeeding,
  • Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might have compromised the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might have interfered with the absorption, distribution, metabolism or excretion of study drug, or would have placed the subject at increased risk,
  • A sustained supine systolic blood pressure > 140 mmHg or < 100 mmHg or a diastolic blood pressure > 95 mmHg at screening or baseline,
  • A resting ECG heart rate of < 50 bpm or > 100 bpm,
  • An abnormal screening ECG indicating a second- or third-degree AV block, or one or more of the following: QRS > 110 milliseconds (ms), QTc (Fridericia correction) > 450 ms for male and 470 ms for females, PR interval > 240 ms. Any rhythm other than sinus rhythm, which was interpreted by the Investigator to be clinically significant,
  • The presence of abnormal laboratory values which were considered clinically significant by the Investigator,
  • Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2),
  • Received an investigational drug within a period of 30 days prior to enrolment in the study,
  • Received any drug therapy, excluding hormonal contraceptives, within 2 weeks prior to administration of the first dose of any study-related treatment. This exclusion was extended to 4 weeks for any drugs known to induce or inhibit hepatic drug metabolism,
  • Consumption of alcohol within 48 hours prior to dose administration or during any inpatient period,
  • A positive urine drug screen including or a positive alcohol breath test,
  • Any history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction,
  • A history of difficulty with donating blood,
  • Donated blood or blood products within 45 days prior to enrollment,
  • History of tendonitis or tendon rupture associated with treatment with quinolone antibiotics,
  • Subjects with, or with a history of, additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or a family history of long QT syndrome or family history of sudden death.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01532115

Locations
France
Biotrial, 7-9 rue Jean-Louis Bertrand
Rennes, France, F-35000
Sponsors and Collaborators
Bial - Portela C S.A.
Investigators
Principal Investigator: Marie-Claude Homery, MD Biotrial
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT01532115     History of Changes
Other Study ID Numbers: BIA-91067-111
Study First Received: January 23, 2012
Last Updated: June 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Bial - Portela C S.A.:
Parkinson Disease
BIA 9-1067

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014