Safety and Tolerability Study With Single Ascending Doses of ODM-102

NCT ID: NCT01839019

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of escalating single doses of ODM-102 in healthy volunteers

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo.

Group Type: PLACEBO_COMPARATOR

Placebo for ODM-102

Intervention Type: DRUG

Single dose escalation

ODM-102

Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo.

Group Type: EXPERIMENTAL

ODM-102

Intervention Type: DRUG

Single dose escalation

Interventions

ODM-102

Single dose escalation

Intervention Type: DRUG

Placebo for ODM-102

Single dose escalation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent (IC) obtained.
• Good general health ascertained by detailed medical history and physical examination.
• Finnish-speaking males between 18 and 45 years of age (inclusive).
• Body mass index (BMI) between 18.0-30.5 kg/m2 (inclusive).
• Weight 55.0-100.0 kg (inclusive).

Exclusion Criteria

• Suspected poor compliance or inability to communicate well with the investigator.
• Veins unsuitable for repeated venipuncture.
• Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator.
• Any condition requiring regular concomitant drug treatment, including herbal products, or likely to need any concomitant drug treatment during the study.
• Susceptibility to severe allergic reactions.
• Intake of any medication that could affect the outcome of the study within 2 weeks prior to the first study drug administration or within less than 5 times the elimination half-life of the medication.
• Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol).
• Current use of nicotine-containing products more than 5 cigarettes or equivalent/day.
• Inability to refrain from using nicotine-containing products during the stay in the study centre.
• Inability to refrain from consuming caffeine-containing beverages during the first 24 hours after treatment administration e.g. propensity to experience headache when abstaining from caffeine-containing beverages.
• Blood donation or loss of a significant amount of blood within 2 months prior to the screening visit.
• Abnormal 12-lead ECG finding of clinical relevance after 10 min rest in supine position at the screening visit
• HR < 45 beats/minute or > 90 beats/minute after 10 minutes rest in supine position at the screening visit.
• At the screening visit, systolic BP < 90 mmHg or > 140 mmHg after 10 minutes in supine position, diastolic BP < 50 mmHg or > 90 mmHg after 10 minutes in supine position, or symptomatic orthostatic hypotension, or decrease of ≥ 20 mmHg of systolic BP or decrease of ≥ 10 mmHg of diastolic BP after 3 minutes in standing position.
• Abnormal 24-hour Holter ECG recording of possible or confirmed clinical relevance
• Any abnormal laboratory value, vital sign, or physical examination finding, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk to the subject if he takes part in the study.
• Suspected current use of illicit drugs (according to medical history enquiry or physical examination), positive drug screen or history of long-term drug abuse.
• Positive serology to human immunodeficiency virus antigen/antibodies (HIVAgAb), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibodies (HCVAb).
• Participation in another clinical drug study within 3 months prior to the first treatment administration in this study.
• Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the subject.

• 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

Mika Scheinin, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Services Turku, CRST

Locations

Clinical Research Services Turku, CRST

Turku, , Finland

Countries

Finland

Other Identifiers

3099003

Identifier Type: -

Identifier Source: org_study_id