Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide

NCT02169895 | Completed Phase 1 Results

• 1 other identifier: BIA-91067-107
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25)

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's disease (PD); Opicapone; Bia 9-1067

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Drug Concentration (Cmax)

  Cmax - Maximum observed plasma drug concentration of benserazide

  pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose

• Tmax - Time of Occurrence of Cmax

  tmax - time of occurrence of Cmax of benserazide

  pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose

• AUC0-t - Area Under the Plasma Concentration-time Curve

  AUC0-t - area under the plasma concentration-time curve of benserazide.

  pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.

Study Arms (4)

Group 1

EXPERIMENTAL

Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo Every period with concomitant single oral administration of Prolopa® 100-25

Drug: BIA 9-1067; Drug: Placebo; Drug: Prolopa®

Group 2

EXPERIMENTAL

Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg Every period with concomitant single oral administration of Prolopa® 100-25

Drug: BIA 9-1067; Drug: Placebo; Drug: Prolopa®

Group 3

EXPERIMENTAL

Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg Every period with concomitant single oral administration of Prolopa® 100-25

Drug: BIA 9-1067; Drug: Placebo; Drug: Prolopa®

Group 4

ACTIVE COMPARATOR

Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg Every period with concomitant single oral administration of Prolopa® 100-25

Drug: BIA 9-1067; Drug: Placebo; Drug: Prolopa®

Interventions

BIA 9-1067 DRUG

Also known as: Opicapone, OPC

Group 1; Group 2; Group 3; Group 4

Placebo DRUG

Also known as: PLC, Placebo

Group 1; Group 2; Group 3; Group 4

Prolopa® DRUG

levodopa/benserazide 100/25 mg

Also known as: Prolopa® 100-25

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Availability for the entire study period and willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer prior to participation in the study.
• Male volunteers.
• Volunteers of at least 25 years of age but not older than 45 years.
• Volunteers with body mass index (BMI) greater than or equal to 19 and below 30 kg/m2.
• Volunteers who are non- or ex-smokers. An ex-smoker is defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
• Volunteers who are healthy as determined by pre-study (at screening) medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.
• Volunteers who have clinical laboratory test results judged clinically acceptable (within the laboratory's stated normal range; if not within this range, they must be without any clinical significance) at screening and admission to first treatment period.
• Volunteers who have negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.
• Volunteers who have negative screen of ethyl alcohol and drugs of abuse at screening.
• Due to unknown risks and potential harm to the unborn fetus, sexually active men must agree to use a medically acceptable form of contraception throughout the study.

You may not qualify if:

• Volunteers who have a clinically relevant surgical history.
• Volunteers who have a clinically relevant family history.
• Volunteers who have a history of relevant atopy.
• Volunteers who have a significant infection or known inflammatory process at screening or first admission.
• Volunteers who have acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).
• Volunteers who are vegetarians, vegans or have medical dietary restrictions.
• Volunteers who cannot communicate reliably with the investigator.
• Volunteers who are unlikely to co-operate with the requirements of the study.
• Significant history of hypersensitivity to BIA 9-1067, tolcapone, entacapone, levodopa, benserazide or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
• Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
• History of significant gastrointestinal, liver or kidney disease that may affect drug bioavailability.
• Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, lymphatic, musculoskeletal, genitourinary, endocrine, immunologic, dermatologic or connective tissue disease.
• Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases.
• Presence of significant heart disease or disorder according to ECG.
• Presence of suspicious undiagnosed skin lesions or a history of melanoma.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Algorithme Pharma Inc

Mount Royal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

opicapone; benserazide, levodopa drug combination

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

Publication Agreements

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

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 20, 2012
• First Posted: June 23, 2014
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: January 15, 2015
• Results First Posted: January 15, 2015

Record last verified: 2015-01

Locations

CA (1)