Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers
NOCIFIM
1 other identifier
interventional
101
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started May 2013
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2013
CompletedFirst Posted
Study publicly available on registry
April 25, 2013
CompletedStudy Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 1, 2015
March 1, 2015
1.6 years
April 23, 2013
March 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Erythrocyte Catechol-O-methyltransferase (COMT) inhibition.
Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)
0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose
Secondary Outcomes (1)
Area under the plasma concentration curve (AUC)
0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose
Study Arms (3)
ODM-104
EXPERIMENTALOral capsules dosage 10-800mg once daily for one day or three times daily for 7 days
Placebo
PLACEBO COMPARATOROral capsules given once daily for one day or three times daily for 7 days
entacapone + levodopa/carbidopa
ACTIVE COMPARATORentacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day
Interventions
Eligibility Criteria
You may qualify if:
- Male subjects aged between 18 and 45 years
- BMI 18-30 kg/m2
- Weight 55-95kg
- Written informed consent
- Good General Health
You may not qualify if:
- Vulnerable subjects
- Veins unsuitable for repeated venipuncture
- Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
- History of or positive test for drug abuse
- Any condition requiring regular concomitant medication
- Blood donation or significant loss of blood within 2 months prior to screening
- Abnormal 12 lead ECG finding of clinical relevance
- Heart rate (HR) \<50bpm or \>90bpm after 10 minutes in a supine position
- Systolic blood pressure \<90mmHg or \>140mmHg after 10 minutes in a supine position
- Diastolic blood pressure \<50mmHg or \>90mmHg after 10 minutes in a supine position
- Abnormal 24 hour Holter recording of clinical relevance at screening
- Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parexel International GmbH
Berlin, Germany
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Rainard Fuhr, MD
Parexel
- STUDY DIRECTOR
angela ruck, PhD
Orion Corporation, Orion Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2013
First Posted
April 25, 2013
Study Start
May 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
April 1, 2015
Record last verified: 2015-03