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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bial - Portela C S.A.
• Treatments: Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Opicapone

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.