Clinical trial NCT01840423: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-104: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: First in man study
Volunteer study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 101
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.

Detailed description: The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-104 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-104.

Eligibility criteria: Inclusion Criteria:

* Male subjects aged between 18 and 45 years
* BMI 18-30 kg/m2
* Weight 55-95kg
* Written informed consent
* Good General Health

Exclusion Criteria:

* Vulnerable subjects
* Veins unsuitable for repeated venipuncture
* Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
* History of or positive test for drug abuse
* Any condition requiring regular concomitant medication
* Blood donation or significant loss of blood within 2 months prior to screening
* Abnormal 12 lead ECG finding of clinical relevance
* Heart rate (HR) \<50bpm or \>90bpm after 10 minutes in a supine position
* Systolic blood pressure \<90mmHg or \>140mmHg after 10 minutes in a supine position
* Diastolic blood pressure \<50mmHg or \>90mmHg after 10 minutes in a supine position
* Abnormal 24 hour Holter recording of clinical relevance at screening
* Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer

Primary outcomes:
measure: Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
timeFrame: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose
Secondary outcomes:
measure: Area under the plasma concentration curve (AUC)
timeFrame: 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: Parexel
name: Rainard Fuhr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orion Corporation, Orion Pharma
name: angela ruck, PhD
role: STUDY_DIRECTOR
References: