Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Carbidopa; Entacapone; Levodopa

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