Clinical trial NCT01532115: Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Parkinson Disease
BIA 9-1067
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Number and percentage of subjects with ECG abnormalities
timeFrame: 56 days
Secondary outcomes:
measure: Number of participants with Adverse Events
timeFrame: 56 days
Other outcomes:
Locations:
city: Rennes
country: France
facility: Biotrial, 7-9 rue Jean-Louis Bertrand
Study officials:
affiliation: Biotrial
name: Marie-Claude Homery, MD
role: PRINCIPAL_INVESTIGATOR
References: