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

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. Identifier: NCT01532115
Recruitment Status : Completed
First Posted : February 14, 2012
Last Update Posted : June 21, 2012
Information provided by (Responsible Party):
Bial - Portela C S.A.

Brief Summary:
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 or disease Intervention/treatment Phase
Parkinson Disease Drug: BIA 9-1067 Drug: Placebo Drug: moxifloxacin Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : May 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BIA 9-1067 Drug: BIA 9-1067
50 mg and 800 mg of BIA 9-1067 (single-dose)

Placebo Comparator: Placebo Drug: Placebo

Active Comparator: moxifloxacin Drug: moxifloxacin
400 mg moxifloxacin (single-dose)

Primary Outcome Measures :
  1. Number and percentage of subjects with ECG abnormalities [ Time Frame: 56 days ]
    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 :
  1. Number of participants with Adverse Events [ Time Frame: 56 days ]
    assessment of safety and tolerability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01532115

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

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Responsible Party: Bial - Portela C S.A. Identifier: NCT01532115    
Other Study ID Numbers: BIA-91067-111
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012
Keywords provided by Bial - Portela C S.A.:
Parkinson Disease
BIA 9-1067
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Catechol O-Methyltransferase Inhibitors
Antiparkinson Agents
Anti-Dyskinesia Agents