FIMPAM: Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers

• Sponsor: Orion Corporation, Orion Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02393950
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer Study	Drug: ODM-106; Drug: Placebo	Phase 1

Detailed Description

Eight planned dose levels of ODM-106 will be compared with placebo.There will be 2 panels of subjects with 4 dose levels in each panel. Subjects will be randomised to receive 3 dose levels of active treatment (single doses) and 1 dose of placebo. The dose levels will be escalated from the smallest dose upwards within the study and within the study subject. A third panel of 8 subjects may be included to investigate further dose levels of ODM-106, investigate the effect of taking ODM-106 with food or to compare two different formulations of ODM-106. For an individual subject, the study will consist of a screening period (maximum 4 weeks), 4 study treatment periods with a wash-out period between each study treatment administration and a post-treatment period of about 2 weeks.

The study duration for an individual will be approximately 12-16 weeks. Blood samples will be collected for the assessment of the concentration of ODM-106 and its metabolite.Plasma samples and cumulative urinary samples will be collected for metabolite screening. Safety will be assessed by a 12-lead electrocardiogram (ECG), continuous ECG monitoring, Holter ECG, supine and orthostatic blood pressure and heart rate, body temperature, physical examination, electroencephalogram (EEG), laboratory safety assessments and adverse events. Sedation and psychomotor tests and a quantitative EEG will also be performed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Single Escalating Doses of ODM-106: A Randomised, Double-blind, Placebo-controlled Single Centre Study in Healthy Males
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Drug: ODM-106 Oral capsules dosage 2-800mg once daily for one day	Drug: ODM-106; Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.
Placebo Comparator: Drug: Placebo Oral capsules given once daily for one day	Drug: Placebo; Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability. [From screening up to 16 weeks]

   Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.

Secondary Outcome Measures

1. Peak Plasma Concentration (cMax) of ODM-106 [Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.]

   cMax of ODM-106 after single dosing of either Capsule B or Capsule A

2. Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106 [Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level]

   AUC of ODM-106 after single oral dosing of either Capsule B or Capsule A.

3. Time to Peak Plasma Concentration (Tmax) of ODM-106 [Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level]

   tmax of ODM-106 after single oral dosing of Capsule B or Capsule A

4. Elimination Half-life of ODM-106 [Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.]

   Elimination half-life of ODM-106 after single dosing of either Capsule B or Capsule A

5. Metabolite Screening in Plasma and Urine [Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level]

   Metabolite screening in plasma and urine after single dosing

6. Effect of ODM-106 on Growth Hormone Levels [Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.]

   Growth hormone levels (Cmax) in serum after single oral dosing with either ODM-106 Capsule B, ODM-106 Capsule A or placebo.

7. Sedation Scores on a Visual Analogue Scale (VAS) [Pre-dose and at 1, 6 and 10.5h post dose at each dose level]

   Assessment of sedation by subject

8. Dexterity and Reaction Times [Pre-dose and at 1 and 6h post dose at each dose level]

   Selected battery of psychomotor tests

9. Quantitative EEG [Pre-dose and at 1, 6 and 10 h post dose at each dose level]

   Quantitative analysis of EEG

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Written informed consent obtained.

• Participants must be able to speak, read and understand German.

• Good general health ascertained by detailed medical history and physical examinations.

• Males 18-45 years (inclusive).

• Body mass index (BMI) 18-30 kg/m2 inclusive

• Weight 55-95 kg (inclusive).

• Participants with female partners of child-bearing potential must adhere to a proper form of contraception from first study treatment administration until 3 months after the end-of-study visit.

Exclusion Criteria:

• A predictable poor compliance or inability to understand and comply with protocol requirements, instructions and protocol-stated restrictions or communicate well with the investigator.

• Vulnerable subjects.

• Veins unsuitable for repeated venipuncture.

• Evidence of clinically relevant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator. The participants should be healthy subjects.

• Subjects with a medical history of relevant psychiatric disorders or evidence of significant neuropsychiatric disease

• Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study.

• Definite or suspected personal history of hypersensitivity to drugs or excipients.

• Intake of any medication that could affect the outcome of the study, as judged by the investigator, within 2 weeks before first study treatment administration (2 months for enzyme inducing drugs like rifampicin or carbamazepin), or less than 5 times the half-life of the medication.

• A history of alcoholism or excess alcohol intake (including regular consumption of more than 21 units of alcohol per week) .

• Use of nicotine-containing products within 6 months of admission and inability to refrain from using nicotine-containing products during the study.

• History of drug abuse or positive drug screen for amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, methamphetamine or methadone.

• Propensity to get headache when refraining from caffeine-containing beverages.

• Blood donation or loss of clinically relevant amount of blood within 2 months before the screening visit.

• Abnormal 12-lead ECG finding of clinical relevance at the screening visit

• Heart rate (HR) < 50 bpm or > 90 bpm after 10 min in rest (supine) at the screening visit

• At the screening visit: systolic BP < 90 mmHg or > 140 mmHg, diastolic BP < 50 mmHg or

90 mmHg, orthostatic hypotension decrease of greater than or equal to 20 mmHg for systolic BP, decrease of greater than or equal to 10 mmHg for diastolic BP.

• Abnormal 24-h Holter of clinical relevance at the screening visit,

• Positive serology to human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies.

• Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part in the study.

• Participation in an investigational drug study within 2 months before entry into this study.

• An employee, a direct or indirect relative of the employee of the contract research organisation or the sponsor.

• 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.

• Subject with abnormal standard EEG judged as clinically relevant by the investigator at screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel International GmbH	Berlin		Germany

Sponsors and Collaborators

• Orion Corporation, Orion Pharma

Investigators

• Principal Investigator: Rainard Fuhr, MD, Parexel International GmbH, Berlin, Germany
• Study Director: John Whiteside, Orion Corporation, Orion Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orion Corporation, Orion Pharma
• ClinicalTrials.gov Identifier: NCT02393950
• Other Study ID Numbers: 3117001; 2014-001317-33
• First Posted: Mar 20, 2015
• Last Update Posted: Dec 23, 2016
• Last Verified: Mar 1, 2016

Study Results

Participant Flow

Recruitment Details	Healthy male volunteers were recruited
Pre-assignment Detail	Screening : Male subjects were screened and following PE, vital signs, EEG, ECG and lab. assessments were randomised into the study. Sixteen subjects were randomised to 2 panels of 8, each subject received 3 single doses of ODM-106 and 1 dose of placebo in a randomised crossover design. Panel 1 was completed before Panel 2 commenced dosing.

Arm/Group Title	Panel 1	Panel 2
Arm/Group Description	Single oral doses ODM-106 Capsule B: 2, 10, 25, 50 mg , placebo	Single oral doses ODM-106 Capsule B: 100, 100, 200mg. ODM-106 Capsule A 100 mg , placebo
Period Title: Overall Study
STARTED	9	9
Period 1	8	8
Period 2	8	8
Period 3	8	8
Period 4	8	8
COMPLETED	8	8
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Panel 1	Panel 2	Total
Arm/Group Description	Single oral doses ODM-106 Capsule B 2, 10, 25, 50mg, placebo	Single oral doses ODM-106 Capsule B 100, 100, 200 mg. ODM-106 Capsule A 100mg, placebo	Total of all reporting groups
Overall Participants	9	9	18
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	9 100%	18 100%
>=65 years	0 0%	0 0%	0 0%
Gender (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	9 100%	9 100%	18 100%
Region of Enrollment (participants) [Number]
Germany	9 100%	9 100%	18 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events as a Measure of Safety. Number of Participants With Adverse Events Related to Tolerability.
Description	Clinically relevant changes from baseline in safety laboratory assessments (haematology, clinical chemistry, urinalysis), vital signs (pulse and heart rate), 12 lead electrocardiograms, Holter electrocardiograms, telemetry, physical examination.
Time Frame	From screening up to 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ODM-106 Capsule B 2mg	ODM-106 Capsule B 10mg	ODM-106 Capsule B 25mg	ODM-106 Capsule B 50mg	ODM-106 Capsule B 100mg (1 x 100mg)	ODM-106 Capsule B 100mg (10 x 10mg)	ODM-106 Capsule B 200mg	ODM-106 Capsule A 100mg	Placebo
Arm/Group Description	Single oral dose 2 x 1 mg ODM-106 Capsule B	Single oral dose 2 x 5 mg ODM-106 Capsule B	Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B	Single oral dose 5 x 10mg ODM-106 Capsule B	Single oral dose 1 x 100mg ODM-106 Capsule B	Single oral dose 10 x 10mg ODM-106 Capsule B	Single oral dose 20 x 10mg ODM-106 Capsule B	Single oral dose 10 x 10mg ODM-106 Capsule A	2 placebo subjects per Arm with matched number of placebo capsules.
Measure Participants	6	6	6	6	6	6	6	6	16
Number [subjects affected]	0	4	5	1	2	1	3	2	3

2. Secondary Outcome

Title	Peak Plasma Concentration (cMax) of ODM-106
Description	cMax of ODM-106 after single dosing of either Capsule B or Capsule A
Time Frame	Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ODM-106 Capsule B 2mg	ODM-106 Capsule B 10mg	ODM-106 Capsule B 25mg	ODM-106 Capsule B 50mg	ODM-106 Capsule B 100mg (1 x 100mg)	ODM-106 Capsule B 100mg (10 x 10mg)	ODM-106 Capsule B 200mg	ODM-106 Capsule A 100mg	Placebo
Arm/Group Description	Single oral dose 2 x 1 mg ODM-106 Capsule B	Single oral dose 2 x 5 mg ODM-106 Capsule B	Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B	Single oral dose 5 x 10 mg ODM-106 Capsule B	Single oral dose 1 x 100 mg ODM-106 Capsule B	Single oral dose 10 x 10 mg ODM-106 Capsule B	Single oral dose 20 x 10 mg ODM-106 Capsule B	Single oral dose 10 x 10 mg ODM-106 Capsule A	2 placebo subjects per Arm with matched number of placebo capsules.
Measure Participants	6	6	6	6	6	6	6	6	0
Mean (Standard Deviation) [ng/ml]	9.1 (4.2)	18.4 (11.4)	67.8 (51.7)	119.2 (60.1)	22.0 (20.1)	225.9 (177.2)	547.7 (319.5)	8.3 (9.1)

3. Secondary Outcome

Title	Area Under the Plasma Concentration Versus Time Curve (AUC) of ODM-106
Description	AUC of ODM-106 after single oral dosing of either Capsule B or Capsule A.
Time Frame	Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine sampling, pre-dose and for 24 hours post dose at each dose level

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ODM-106 Capsule B 2mg	ODM-106 Capsule B 10mg	ODM-106 Capsule B 25mg	ODM-106 Capsule B 50mg	ODM-106 Capsule B 100mg (1 x 100mg)	ODM-106 Capsule B 100mg (10 x 10mg)	ODM-106 Capsule B 200mg	ODM-106 Capsule A 100mg	Placebo
Arm/Group Description	Single oral dose 2 x 1 mg ODM-106 Capsule B	Single oral dose 2 x 5 mg ODM-106 Capsule B	Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B	Single oral dose 5 x 10 mg ODM-106 Capsule B	Single oral dose 1 x 100 mg ODM-106 Capsule B	Single oral dose 10 x 10 mg ODM-106 Capsule B	Single oral dose 20 x 10 mg ODM-106 Capsule B	Single oral dose 10 x 10 mg ODM-106 Capsule A	2 placebo subjects per Arm with matched number of placebo capsules.
Measure Participants	6	6	6	6	6	6	6	6	0
Mean (Standard Deviation) [h*ng/ml]	16.9 (8.8)	61.3 (44.1)	213.8 (78.7)	559.4 (310.9)	297.4 (346.3)	1089.2 (977.0)	2850.8 (2319.8)	82.0 (64.7)

4. Secondary Outcome

Title	Time to Peak Plasma Concentration (Tmax) of ODM-106
Description	tmax of ODM-106 after single oral dosing of Capsule B or Capsule A
Time Frame	Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ODM-106 Capsule B 2mg	ODM-106 Capsule B 10mg	ODM-106 Capsule B 25mg	ODM-106 Capsule B 50mg	ODM-106 Capsule B 100mg (1 x 100mg)	ODM-106 Capsule B 100mg (10 x 10mg)	ODM-106 Capsule B 200mg	ODM-106 Capsule A 100mg	Placebo
Arm/Group Description	Single oral dose 2 x 1 mg ODM-106 Capsule B	Single oral dose 2 x 5 mg ODM-106 Capsule B	Single oral dose 2 x 10 mg 1 x 5mg ODM-106 Capsule B	Single oral dose 5 x 10 mg ODM-106 Capsule B	Single oral dose 1 x 100 mg ODM-106 Capsule B	Single oral dose 10 x 10 mg ODM-106 Capsule B.	Single oral dose 20 x 10 mg ODM-106 Capsule B	Single oral dose 10 x 10 mg ODM-106 Capsule A.	2 placebo subjects per Arm with matched number of placebo capsules.
Measure Participants	6	6	6	6	6	6	6	6	0
Mean (Full Range) [h]	0.7	1.9	1.5	2.1	5.8	1.5	1.5	3.0

5. Secondary Outcome

Title	Elimination Half-life of ODM-106
Description	Elimination half-life of ODM-106 after single dosing of either Capsule B or Capsule A
Time Frame	Pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ODM-106 Capsule B 2mg	ODM-106 Capsule B 10mg	ODM-106 Capsule B 25mg	ODM-106 Capsule B 50mg	ODM-106 Capsule B 100mg (1 x 100mg)	ODM-106 Capsule B 100mg (10 x 10mg)	ODM-106 Capsule B 200mg	ODM-106 Capsule A 100mg	Placebo
Arm/Group Description	Single oral dose 2 x 1 mg ODM-106 Capsule B.	Single oral dose 2 x 5 mg ODM-106 Capsule B.	Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B.	Single oral dose 5 x 10 mg ODM-106 Capsule B.	Single oral dose 1 x 100 mg ODM-106 Capsule B.	Single oral dose 10 x 10 mg ODM-106 Capsule B.	Single oral dose 20 x 10 mg ODM-106 Capsule B.	Single oral dose 10 x 10 mg ODM-106 Capsule A.	2 placebo subjects per Arm with matched number of placebo capsules.
Measure Participants	6	6	6	6	6	6	6	6	0
Mean (Standard Deviation) [h]	9.5 (5.5)	20.6 (12.7)	23.0 (2.1)	27.3 (4.7)	23.5 (6.3)	27.4 (9.2)	32.1 (10.0)	21.7 (3.2)

6. Secondary Outcome

Title	Metabolite Screening in Plasma and Urine
Description	Metabolite screening in plasma and urine after single dosing
Time Frame	Plasma samples at pre-dose and 15, 30 and 45 min, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, 72 and 96 hours post dose at each dose level. Urine samples, pre-dose and for 24 hours post dose at each dose level

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Effect of ODM-106 on Growth Hormone Levels
Description	Growth hormone levels (Cmax) in serum after single oral dosing with either ODM-106 Capsule B, ODM-106 Capsule A or placebo.
Time Frame	Predose and 1, 2, 3,4, 6 and 8 hours post dose at each dose level.

Outcome Measure Data

Analysis Population Description

Only timepoints 2 - 6h evaluated.

Arm/Group Title	ODM-106 Capsule B 2mg	ODM-106 Capsule B 10mg	ODM-106 Capsule B 25mg	ODM-106 Capsule B 50mg	ODM-106 Capsule B 100mg (1 x 100mg)	ODM-106 Capsule B 100mg (10 x 10mg)	ODM-106 Capsule B 200mg	ODM-106 Capsule A 100mg	Placebo
Arm/Group Description	Single oral dose 2 x 1 mg ODM-106 Capsule B	Single oral dose 2 x 5 mg ODM-106 Capsule B	Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B	Single oral dose 5 x 10mg ODM-106 Capsule B	Single oral dose 1 x 100mg ODM-106 Capsule B	Single oral dose 10 x 10mg ODM-106 Capsule B	Single oral dose 20 x 10mg ODM-106 Capsule B	Single oral dose 10 x 10mg ODM-106 Capsule A	2 placebo subjects per Arm with matched number of placebo capsules.
Measure Participants	5	5	6	5	6	6	6	6	14
Geometric Mean (Standard Deviation) [ng/ml]	1.7 (3.2)	0.47 (1.04)	1.05 (2.88)	1.93 (1.99)	0.8 (1.36)	2.23 (6.12)	0.82 (0.68)	4.14 (4.96)	1.01 (2.45)

8. Secondary Outcome

Title	Sedation Scores on a Visual Analogue Scale (VAS)
Description	Assessment of sedation by subject
Time Frame	Pre-dose and at 1, 6 and 10.5h post dose at each dose level

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Dexterity and Reaction Times
Description	Selected battery of psychomotor tests
Time Frame	Pre-dose and at 1 and 6h post dose at each dose level

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Quantitative EEG
Description	Quantitative analysis of EEG
Time Frame	Pre-dose and at 1, 6 and 10 h post dose at each dose level

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	From the start of study treatment until the end of study visit (approximately 12-16 weeks)
Adverse Event Reporting Description	16 subjects were randomised into 2 panels of 8 subjects. Each panel of 8 subjects participated in 4 periods as a crossover, during each period 6 subjects received active and 2 subjects received placebo, There was a 2 week washout between each period.
Arm/Group Title	ODM-106 Capsule B 2mg		ODM-106 Capsule B 10mg		ODM-106 Capsule B 25mg		ODM-106 Capsule B 50mg		ODM-106 Capsule B 100mg (1 x 100mg)		ODM-106 Capsule B 100mg (10 x 10mg)		ODM-106 Capsule B 200mg		ODM-106 Capsule A 100mg		Placebo
Arm/Group Description	Single oral dose 2 x 1 mg ODM-106 Capsule B		Single oral dose 2 x 5 mg ODM-106 Capsule B		Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B		Single oral dose 5 x 10 mg ODM-106 Capsule B		Single oral dose 1 x 100 mg ODM-106 Capsule B		Single oral dose 10 x 10 mg ODM-106 Capsule B		Single oral dose 20 x 10 mg ODM-106 Capsule B		Single oral dose 10 x 10 mg ODM-106 Capsule A		2 placebo subjects per Arm with matched number of placebo capsules
All Cause Mortality
	ODM-106 Capsule B 2mg		ODM-106 Capsule B 10mg		ODM-106 Capsule B 25mg		ODM-106 Capsule B 50mg		ODM-106 Capsule B 100mg (1 x 100mg)		ODM-106 Capsule B 100mg (10 x 10mg)		ODM-106 Capsule B 200mg		ODM-106 Capsule A 100mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ODM-106 Capsule B 2mg		ODM-106 Capsule B 10mg		ODM-106 Capsule B 25mg		ODM-106 Capsule B 50mg		ODM-106 Capsule B 100mg (1 x 100mg)		ODM-106 Capsule B 100mg (10 x 10mg)		ODM-106 Capsule B 200mg		ODM-106 Capsule A 100mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	ODM-106 Capsule B 2mg		ODM-106 Capsule B 10mg		ODM-106 Capsule B 25mg		ODM-106 Capsule B 50mg		ODM-106 Capsule B 100mg (1 x 100mg)		ODM-106 Capsule B 100mg (10 x 10mg)		ODM-106 Capsule B 200mg		ODM-106 Capsule A 100mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		4/6 (66.7%)		5/6 (83.3%)		1/6 (16.7%)		2/6 (33.3%)		1/6 (16.7%)		3/6 (50%)		2/6 (33.3%)		3/16 (18.8%)
Cardiac disorders
RHYTHM IDIOVENTRICULAR	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
VENTRICULAR EXTRASYSTOLES	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
Ear and labyrinth disorders
EAR DISCOMFORT	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
Gastrointestinal disorders
DIARRHOEA	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/16 (6.3%)	1
NAUSEA	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
Infections and infestations
ABCESS LIMB	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/16 (0%)	0
GASTROENTERITIS	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
NASAL HERPES	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
NASOPHARYNGITIS	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	3/6 (50%)	3	0/6 (0%)	0	0/16 (0%)	0
RHINITIS	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
URINARY TRACT INFECTION	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
Injury, poisoning and procedural complications
SUNBURN	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
Musculoskeletal and connective tissue disorders
MYALGIA	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
Nervous system disorders
DISTURBANCE IN ATTENTION	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
DYSGEUSIA	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/16 (6.3%)	1
HEADACHE	0/6 (0%)	0	1/6 (16.7%)	1	4/6 (66.7%)	4	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/16 (6.3%)	1
Respiratory, thoracic and mediastinal disorders
EPISTAXIS	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	0/16 (0%)	0
NASAL DRYNESS	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	0/16 (0%)	0
OROPHARYNGEAL PAIN	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
PRODUCTIVE COUGH	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/16 (0%)	0
Skin and subcutaneous tissue disorders
HYPERHIDROSIS	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/16 (0%)	0
RASH	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/16 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.