Pharmacokinetic Study in Healthy Males

NCT02312232 | Completed Phase 1

• 1 other identifier: 3112002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of 3 levodopa formulations given in combination with carbidopa and ODM-104.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (Cmax) of levodopa

  Peak Plasma Concentration (Cmax)

  24 hours

Secondary Outcomes (1)

• Pharmacokinetics (Cmax) of carbidopa, 3-OMD and ODM-104

  24 hours

Study Arms (5)

Levodopa formulation A

EXPERIMENTAL

Levodopa formulation A together with ODM-104 100 mg and carbidopa

Drug: levodopa, carbidopa, ODM-104

levodopa formulation B

EXPERIMENTAL

levodopa formulation B together with ODM-104 100 mg and carbidopa

Drug: levodopa, carbidopa, ODM-104

levodopa formulation C

EXPERIMENTAL

levodopa formulation C together with ODM-104 100 mg and carbidopa

Drug: levodopa, carbidopa, ODM-104

Sinemet IR 100/25 mg

ACTIVE COMPARATOR

Sinemet IR 100/25 mg together with ODM-104 100 mg

Drug: levodopa, carbidopa, ODM-104

Half Sinemet CR 100/25 mg

ACTIVE COMPARATOR

Half Sinemet CR 100/25 mg together with ODM-104 100 mg

Drug: levodopa, carbidopa, ODM-104

Interventions

levodopa, carbidopa, ODM-104 DRUG

Also known as: Sinemet

Half Sinemet CR 100/25 mg; Levodopa formulation A; Sinemet IR 100/25 mg; levodopa formulation B; levodopa formulation C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• 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 18-65 years of age (inclusive).
• Normal weight defined as a body mass index (BMI) \> 19 and \< 32 kg/m2 (BMI = weight/height2).
• Weight at least 60 kg.
• Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems).
• Participants with female partners of child-bearing potential 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, malignancy, neurological or psychiatric disease within the previous 2 years.
• Inherited or family history (parents, siblings) of clinically significant cardiac conduction disease.
• Current/history of inflammatory bowel disease (IBDs): Colitis ulcerosa and Crohn's disease, celiac disease. Acute duodenal or gastric ulcer or gastritis, esophagitis, colon polyps or anal fissure.
• 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.
• 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 may interfere with the interpretation of study results or constitute a health risk for the subject if he takes part in the study.
• Known hypersensitivity to the active substances or the excipients of the drugs.
• History of vasovagal collapses or vagal reactions with unexplained reason within 2 years or a tendency for vasovagal reactions during blood sampling.
• History of sleep apnea.
• Heart rate (HR) \< 40 bpm or \> 90 bpm after 10 minutes in supine position at the screening visit and predose.
• At the screening visit:
• systolic blood pressure (BP) \< 90 mmHg or \> 150 mmHg after 10 minutes in supine position diastolic BP \< 50 mmHg or \> 90 mmHg after 10 minutes in supine position
• Abnormal 24-hour Holter findings of clinical relevance according to cardiologist´s assessment at the screening visit.
• History of anaphylactic/anaphylactoid reactions.
• History of seizures excluding febrile seizures during the first 6 years of life.

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

CRST

Turku, 20520, Finland

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Levodopa; Carbidopa; carbidopa, 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

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

  CRST Turku

  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: December 2, 2014
• First Posted: December 9, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

FI (1)