Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Male subjects aged between 18 and 45 years
- BMI 18-30 kg/m2
- Weight 55-95kg
- Written informed consent
- Good General Health
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01840423
Start Date
May 1 2013
End Date
December 1 2014
Last Update
April 1 2015
Active Locations (1)
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1
Parexel International GmbH
Berlin, Germany