Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young Subjects

NCT02092168 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.

Conditions

Parkinson Disease

Keywords

Opicapone; BIAL

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Plasma Concentration

  Cmax (BIA 9-1067) - maximum plasma concentration of BIA 9-1067

  Day 1 and Day 7

• Tmax - Time to Reach Cmax

  Tmax - Time to reach maximum plasma concentration of BIA 9-1067

  Day 1 and Day 7

• AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration

  AUC0-t - Area under the plasma concentration-time curve of BIA 9-1067 from time 0 to last observed concentration

  Day 1 and Day 7

Study Arms (2)

BIA 9-1067 30 mg (once daily) - Elderly Subjects

EXPERIMENTAL

BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.

Drug: BIA 9-1067

BIA 9-1067 30 mg (once daily) - Young Subjects

EXPERIMENTAL

BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.

Drug: BIA 9-1067

Interventions

BIA 9-1067 DRUG

Also known as: Opicapone, OPC

BIA 9-1067 30 mg (once daily) - Elderly Subjects; BIA 9-1067 30 mg (once daily) - Young Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects (young and elderly):
• A signed and dated informed consent form before any study-specific screening procedure is performed.
• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead electrocardiogram (ECG).
• Non-smoker or smoker of fewer than 10 cigarettes per day as determined by history. Had to be able to abstain from smoking during the inpatient stay.
• With a body mass index (BMI) between 19 and 30 kg/m2, inclusive.
• Young subjects only:
• Males aged between 18 and 40 years, inclusive.
• Elderly subjects only:
• Males older than 65 years, inclusive.

You may not qualify if:

• All subjects (young and elderly):
• General
• Subjects who had participated in a clinical trial with an investigational drug within the 90 days prior to screening.
• Subjects who were likely to be noncompliant with the protocol, or who were felt to be unsuitable by the Investigator for any other reason.
• Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
• Positive findings of urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA \[3,4-ethylenedioxymethamphetamine; ecstasy\]).
• Medical History
• Any significant cardiovascular, hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes,), immunological, dermatological, haematological, neurological, or psychiatric disease and history thereof.
• Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study Day 1.
• History of drug abuse within 1 year before study Day 1.
• History of alcoholism within 1 year before Day 1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° \[10%\] wine = 12 g; 4 cL of aperitif, 42° \[42%\] whiskey = 17 g; 25 cL glass of 3° \[3%\] beer = 7.5 g; 25 cL glass of 6° \[6%\] beer = 15 g).
• History of any clinically important drug allergy.
• Had previously received BIA 9-1067.
• Prohibited treatments and dietary restrictions
• Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study Day 1.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

BIOTRIAL

Rueil, Malmaison, F-92501, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Head of Clinical Research
• Organization: Bial - Portela & Cª, S.A.

jose.rocha@bial.com

+351 229 866 100

Study Officials

• Patrício SOARES-DA-SILVA, MD, PhD

  BIAL - Portela & Ca S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: March 20, 2014
• Study Start: October 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: January 14, 2015
• Results First Posted: January 14, 2015

Record last verified: 2015-01

Locations

FR (1)