Clinical trial NCT01839019: Safety and Tolerability Study With Single Ascending Doses of ODM-102
Official title: Safety, Tolerability and Pharmacokinetics of Single Escalating Doses of ODM-102: A Randomised, Double-blind, Placebo-controlled, Single Centre Study in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Safety measures, i.e. assessing adverse events, vital signs, ECG and safety laboratory values
timeFrame: about a month
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 5 days per period
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Clinical Research Services Turku, CRST
Study officials:
affiliation: Clinical Research Services Turku, CRST
name: Mika Scheinin, MD
role: PRINCIPAL_INVESTIGATOR
References: