Healthy VolunteersPhase 1NCT01839019
Safety and Tolerability Study With Single Ascending Doses of ODM-102
A Phase 1 study testing ODM-102 in people with Healthy Volunteers, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The purpose of the study is to evaluate the safety and tolerability of escalating single doses of ODM-102 in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ODM-102
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- ODM-102, Placebo for ODM-102
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ODM-102Drug
Single dose escalation
Placebo for ODM-102Drug
Single dose escalation
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo. Receives: 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. Receives: Drug: ODM-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures, i.e. assessing adverse events, vital signs, ECG and safety laboratory values
Measured: about a month
Secondary outcomes (1)
Pharmacokinetics
Explore the PK profile (e.g. Cmax, tmax, AUC, t1/2), screen circulating metabolites and determine protein binding.
Measured: 5 days per period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mika Scheinin, MD, Principal investigator, Clinical Research Services Turku, CRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839019
- Sponsor's protocol ID
- 3099003
- Status last verified
- Feb 2014
- First submitted
- 17 Apr 2013
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01839019
- Acronym / sponsor ID
- 3099003
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and tolerability of escalating single doses of ODM-102 in healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo for ODM-102Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo. |
| ODM-102 | Experimental | Drug: ODM-102Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ODM-102Single dose escalation | Drug | ODM-102 |
| Placebo for ODM-102Single dose escalation | Drug | Placebo |
Primary outcome
Safety measures, i.e. assessing adverse events, vital signs, ECG and safety laboratory values
Time frame: about a month
1 secondary outcome
Pharmacokinetics
Time frame: 5 days per period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mika Scheinin, MD principal investigator
Clinical Research Services Turku, CRST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ODM-102 in people with Healthy Volunteers, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measures, i.e. assessing adverse events, vital signs, ECG and safety laboratory values (time frame: about a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014; AzTrials last refreshed its copy on 6 Nov 2026.