Pharmacokinetic Study in Healthy Males

• Register: ClinicalTrials.gov
• Last refreshed on: 2 March 2015
• Main ID: NCT02312232
• Date of registration: 02/12/2014
• Prospective Registration: No
• Primary sponsor: Orion Corporation, Orion Pharma
• Public title: Pharmacokinetic Study in Healthy Males NOCOF
• Scientific title: 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
• Date of first enrolment: November 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02312232
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Finland

Contacts

• Name: Mika Scheinin, MD
• Affiliation: CRST Turku

Key inclusion & exclusion 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.

- 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.

- 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 (1
unit = 4 cl spirits or equivalent).

- Current use of nicotine containing products more than 5 cigarettes (or
equivalent)/day and/or inability to refrain from the use of nicotine containing
products during the study (from the screening visit to the end-of-study visit).

- Use of caffeine containing beverages more than 600 mg of caffeine/day and/or
inability to refrain from the use of caffeine containing beverages during the
treatment periods until 24 hours after study treatment administration.

- Blood donation or loss of significant amount of blood within 90 days prior to the
first study treatment administration.

- Administration of another investigational drug within 90 days prior to the first
study treatment administration.

- Unsuitable veins for repeated venipuncture or for cannulation.

- Predictable poor compliance or inability to communicate well with the study centre
personnel.

- Inability to participate in all treatment periods.

- Participation in a clinical drug study during or within 3 months prior to the first
study treatment administration.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: levodopa, carbidopa, ODM-104

Primary Outcome(s)

Pharmacokinetics (Cmax) of levodopa [Time Frame: 24 hours]

Secondary Outcome(s)

Pharmacokinetics (Cmax) of carbidopa, 3-OMD and ODM-104 [Time Frame: 24 hours]

Secondary ID(s)

3112002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors