Pharmacokinetic Study in Healthy Volunteers

NCT02554734 | Completed Phase 1

• 1 other identifier: 3112003
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I open, randomized cross-over pharmacokinetic study.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Levodopa Peak Plasma Concentration (Cmax) and fluctuation of levodopa Cmax/Cmin, tau

  Explore the Cmax of levodopa and fluctuation of levodopa Cmax/Cmin, tau

  Blood samples collected frequently on day 7 for 24 hours.

Secondary Outcomes (8)

• Carbidopa Peak Plasma Concentration (Cmax)

  Blood samples collected frequently on day 7 for 24 hours.

• 3-OMD Peak Plasma Concentration (Cmax)

  Blood samples collected frequently on day 7 for 24 hours.

• Levodopa Cmax, tau

  Blood samples collected frequently on day 7 for 24 hours.

• Levodopa Cmin, tau

  Blood samples collected frequently on day 7 for 24 hours.

• Levodopa Area under the plasma concentration versus time curve (AUC)

  Blood samples collected frequently on day 7 for 24 hours.

Study Arms (3)

Levodopa standard carbidopa

EXPERIMENTAL

Levodopa, carbidopa, ODM-104

Drug: levodopa, carbidopa, ODM-104

Levodopa modified carbidopa

EXPERIMENTAL

Levodopa, carbidopa, ODM-104

Drug: levodopa, carbidopa, ODM-104

Stalevo

ACTIVE COMPARATOR

Levodopa, carbidopa, entacapone

Drug: levodopa, carbidopa, entacapone

Interventions

levodopa, carbidopa, ODM-104 DRUG

Also known as: Sinemet

Levodopa modified carbidopa; Levodopa standard carbidopa

levodopa, carbidopa, entacapone DRUG

Also known as: Stalevo

Stalevo

Eligibility Criteria

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

You may qualify if:

• Written informed consent (IC) obtained
• Good general health ascertained by detailed medical history and physical examinations
• Finnish speaking males and females 18-65 years of age
• Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI=weight/height m2)
• Weight at least 55 kg
• Regular intestinal transit (no recent history of recurrent constipation, diarrhea, or other intestinal problems, and no history of major gastrointestinal surgery)
• Sexually active study subjects, unless surgically sterile must adhere to a proper form of contraception (hormonal contraception or intrauterine device on female partner, and an additional barrier method used at least by one of the partners) from the first study treatment administration until 3 months after the end-of-study visit

You may not qualify if:

• Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease or cancer (except local non-melanoma skin cancer) within the previous 2 years.
• Family history (parents, siblings) of clinically significant cardiac conduction disease.
• Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol for occasional pain is allowed. Hormonal contraception and hormone replacement therapy are allowed.
• Intake of any medication that could affect the outcome of the study.
• Any clinically significant abnormal laboratory value or physical finding (including ECG and vital signs) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he/she takes part in the study.
• Known hypersensitivity to the active substances or the excipients of the drugs.
• Pregnant or lactating females.
• History of vasovagal collapses or vagal reactions with unexplained reason within the previous 2 years or a tendency for vasovagal reactions during blood sampling.
• HR \< 40 bpm or \> 90 bpm in the supine position after 10 min rest at the screening visit.
• At the screening visit:
• systolic BP \< 90 mmHg or \> 150 mmHg in the supine position after 10 min rest diastolic BP \< 50 mmHg or \> 90 mmHg in the supine position after 10 min rest
• History of anaphylactic/anaphylactoid reactions.
• Strong tendency to motion sickness.
• Recent or current (suspected) drug abuse.
• Recent or current alcohol abuse; regular drinking of more than 21 units per week (males) or 16 units per week (females) (1 unit = 4 cl spirits or equivalent).

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Clinical Research Services Turku CRST

Turku, Finland

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; Carbidopa; carbidopa, levodopa drug combination; entacapone; Stalevo

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)

Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Tyrosine; Methyldopa; Hydrazines

Study Officials

• Mika Scheinin, MD

  Clinical Research Services Turku CRST

  PRINCIPAL INVESTIGATOR

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: June 10, 2015
• First Posted: September 18, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

FI (1)