Relative Bioavailability and Bioequivalence of Opicapone

NCT03820037 | Completed Phase 1

• 1 other identifier: BIA-91067-132
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

the purpose assess the relative bioavailability and bioequivalence of two active pharmaceutical ingredient (API) sources of opicapone (OPC, Ongentys® and BIA 9-1067) following single 50 mg dose administration under fasting conditions in healthy volunteers

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• area under the plasma concentration-time curve from time zero to infinity (AUC0 ∞)

  PK parameters from Blood samples to be be collected for the analysis of plasma concentrations of opicapone.

  Day 1 up to day 14

• area under the plasma concentration-time curve from time zero to the last observable concentration at time t (AUC0 t)

  PK parameters from Blood samples to be be collected for the analysis of plasma concentrations of opicapone.

  Day 1 up to day 14

• maximum observed plasma concentration (Cmax)

  PK parameters from Blood samples to be be collected for the analysis of plasma concentrations of opicapone.

  Day 1 up to day 14

Study Arms (2)

OPC, Ongentys

ACTIVE COMPARATOR

Single oral doses of 50 mg opicapone, administered using the reference (Ongentys ®) active pharmaceutical ingredient (API) source

Drug: Ongentys

BIA 9-1067

EXPERIMENTAL

Single oral doses of 50 mg opicapone, administered using the test (BIA 9-1067)

Drug: BIA 9-1067 (test)

Interventions

Ongentys DRUG

single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions

OPC, Ongentys

BIA 9-1067 (test) DRUG

single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions

BIA 9-1067

Eligibility Criteria

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

You may qualify if:

• Males or females, between 18 and 55 years of age, inclusive.
• Body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive.
• Healthy subjects as determined by no clinically significant findings from medical history, physical examination, complete neurological examination, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhaemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at Screening and Check in as assessed by the Investigator (or designee).
• Females will not be pregnant (i.e. the the pregnancy test at screening and at admission to each treatment period must be negative), or lactating, and females of childbearing potential and males will agree to use contraception.
• Able to comprehend and willing to sign and date an Informed Consent Form (ICF) before any study-specific screening procedure is performed, and to abide by the study restrictions.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, lymphatic, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, immunological, connective tissue diseases or disorders, musculoskeletal, psychiatric disorder, or have a clinically relevant surgical history as determined by the Investigator (or designee).
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
• History of febrile illness within 10 days prior to the each dose of study drug, or subjects with evidence of active infection
• Acute gastrointestinal symptoms (eg nausea, vomiting, diarrhoea, heartburn) as determined by the Investigator (or designee).
• Significantly impaired hepatic function, defined as any of the following (confirmed by repeat):
• Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN)
• Total bilirubin (TBL) \> 2 x ULN
• Significant personal or family history of haemostatic disorders
• History of galactose intolerance (eg the Lapp lactase deficiency or glucose-galactose malabsorption)
• Symptomatic orthostatic hypotension (drop of \> 20 mmHg in systolic blood pressure and/or \> 10 mmHg in diastolic blood pressure) when moving from supine to standing position, together with other symptoms, e.g., dizziness.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
• History of alcoholism or drug/chemical abuse within 2 years prior to Check in to the first treatment period.
• Alcohol consumption of \>21 units per week for males and \>14 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
• Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check in to each treatment period.
• Positive hepatitis panel and/or positive human immunodeficiency virus test

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Covance Clinical Research

Leeds, LS2 9LH, United Kingdom

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

Study Design

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

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: March 19, 2019
• Primary Completion: June 9, 2019
• Study Completion: June 9, 2019
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

GB (1)