Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-103 in Healthy Volunteers

NCT ID: NCT01688089

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-09-30

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-103 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-103 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-103 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-103 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-103.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

ODM-103

Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days

Group Type: EXPERIMENTAL

ODM103

Intervention Type: DRUG

Placebo

Oral capsules given once daily for one day or three times daily for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

entacapone + levodopa/carbidopa

entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day

Group Type: ACTIVE_COMPARATOR

Entacapone

Intervention Type: DRUG

Levodopa/carbidopa

Intervention Type: DRUG

Interventions

ODM103

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Entacapone

Intervention Type: DRUG

Levodopa/carbidopa

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male subjects aged between 18 and 45 years
• BMI 18-30 kg/m2
• Weight 55-90kg
• 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 3 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainard Fuhr, MD

Role: PRINCIPAL_INVESTIGATOR

Parexel

Locations

Parexel International GmbH

Berlin, , Germany

Countries

Germany

Other Identifiers

3109001

Identifier Type: -

Identifier Source: org_study_id