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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01532115
• Date of registration: 23/01/2012
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and Women
• Scientific 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
• Date of first enrolment: May 2010
• Target sample size: 64
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01532115
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Marie-Claude Homery, MD
• Affiliation: Biotrial

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: moxifloxacin

Drug: BIA 9-1067

Drug: Placebo

Primary Outcome(s)

Number and percentage of subjects with ECG abnormalities [Time Frame: 56 days]

Secondary Outcome(s)

Number of participants with Adverse Events [Time Frame: 56 days]

Secondary ID(s)

BIA-91067-111

Source(s) of Monetary Support

Please refer to primary and secondary sponsors