Pharmacokinetics of Levodopa, Carbidopa, 3-OMD and ODM-104 After Repeated Doses of Different Formulations: an Open, Randomised, Multicentre Study With Crossover Design in Healthy Males

Orion Corporation, Orion Pharma1 site in 1 country20 target enrollmentNovember 2014

ConditionsParkinson's Disease

Interventionslevodopa, carbidopa, ODM-104

Drugslevodopa, carbidopa, ODM-104

Overview

Phase: Phase 1
Intervention: levodopa, carbidopa, ODM-104
Conditions: Parkinson's Disease
Sponsor: Orion Corporation, Orion Pharma
Enrollment: 20
Locations: 1
Primary Endpoint: Pharmacokinetics (Cmax) of levodopa
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

February 2015

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Orion Corporation, Orion Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.