Parkinson Disease
Conditions
Keywords
Parkinson Disease, BIA 9-1067
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.
Detailed description
Single-centre, randomized, double-blind, placebo-controlled and open-label active-controlled, 4-period crossover trial in healthy male and female subjects
Interventions
DRUGBIA 9-1067
50 mg and 800 mg of BIA 9-1067 (single-dose)
DRUGPlacebo
single-dose
DRUGmoxifloxacin
400 mg moxifloxacin (single-dose)
Sponsors
Bial - Portela C S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and percentage of subjects with ECG abnormalities | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events | 56 days | assessment of safety and tolerability |
Countries
France
Outcome results
None listed