Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women
Phase 1
Completed
- Conditions
- Parkinson Disease
- Interventions
- Registration Number
- NCT01532115
- Lead Sponsor
- 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.
- Detailed Description
Single-centre, randomized, double-blind, placebo-controlled and open-label active-controlled, 4-period crossover trial in healthy male and female subjects
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BIA 9-1067 BIA 9-1067 - Placebo Placebo - moxifloxacin moxifloxacin -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of participants with Adverse Events 56 days assessment of safety and tolerability
Trial Locations
- Locations (1)
Biotrial, 7-9 rue Jean-Louis Bertrand
🇫🇷Rennes, France