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

NCT01839019 | Completed Phase 1 DMC

• 1 other identifier: 3099003
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Safety measures, i.e. assessing adverse events, vital signs, ECG and safety laboratory values

  about a month

Secondary Outcomes (1)

• Pharmacokinetics

  5 days per period

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

ODM-102

EXPERIMENTAL

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

Drug: ODM-102

Interventions

ODM-102 DRUG

Single dose escalation

ODM-102

Placebo for ODM-102 DRUG

Single dose escalation

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Clinical Research Services Turku, CRST

Turku, 20520, Finland

Location

Study Officials

• Mika Scheinin, MD

  Clinical Research Services Turku, CRST

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 24, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

FI (1)