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

Safety, Tolerability and Pharmacokinetics of Single Escalating Doses of ODM-102: A Randomised, Double-blind, Placebo-controlled, Single Centre Study in Healthy Males

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo for ODM-102; Drug: ODM-102

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20520
    • Clinical Research Services Turku, CRST

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo.	Drug: Placebo for ODM-102; Single dose escalation
EXPERIMENTAL: ODM-102; Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo.	Drug: ODM-102; Single dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measures, i.e. assessing adverse events, vital signs, ECG and safety laboratory values	about a month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics	Explore the PK profile (e.g. Cmax, tmax, AUC, t1/2), screen circulating metabolites and determine protein binding.	5 days per period

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 19, 2013
• First Posted (ESTIMATE): April 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 10, 2014
• Last Update Submitted That Met QC Criteria: February 7, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Other Study ID Numbers: 3099003