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

NCT01532115 | Completed Phase 1

• 1 other identifier: BIA-91067-111
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; BIA 9-1067

Outcome Measures

Primary Outcomes (1)

• Number and percentage of subjects with ECG abnormalities

  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.

  56 days

Secondary Outcomes (1)

• Number of participants with Adverse Events

  56 days

Study Arms (3)

BIA 9-1067

EXPERIMENTAL

Drug: BIA 9-1067

Placebo

PLACEBO COMPARATOR

Drug: Placebo

moxifloxacin

ACTIVE COMPARATOR

Drug: moxifloxacin

Interventions

BIA 9-1067 DRUG

50 mg and 800 mg of BIA 9-1067 (single-dose)

BIA 9-1067

Placebo DRUG

single-dose

Placebo

moxifloxacin DRUG

400 mg moxifloxacin (single-dose)

moxifloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Biotrial, 7-9 rue Jean-Louis Bertrand

Rennes, F-35000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone; Moxifloxacin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marie-Claude Homery, MD

  Biotrial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: February 14, 2012
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: May 1, 2011
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

FR (1)