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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers (NOCIFIM)

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ClinicalTrials.gov Identifier: NCT01840423
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE April 25, 2013
Last Update Posted Date April 1, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
Erythrocyte Catechol-O-methyltransferase (COMT) inhibition. [ Time Frame: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose ]
Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
Erythrocyte COMT inhibition. [ Time Frame: 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose ]
Maximal COMT inhibition and area under the COMT inhibition curve AUCC
Change History Complete list of historical versions of study NCT01840423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2014)
Area under the plasma concentration curve (AUC) [ Time Frame: 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose ]
AUC under the plasma concentration curve
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2013)
AUC [ Time Frame: 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose ]
AUC under the plasma concentration curve
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers
Official Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Repeated Escalating Doses of ODM-104: a Randomised, Double-blind, Placebo- and Entacapone-controlled Single Centre First-in-man Study in Healthy Volunteers.
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.
Detailed Description The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-104 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-104.
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: ODM-104
    ODM-104
  • Drug: Placebo
    Placebo
  • Drug: Entacapone
    entacapone + levodopa/carbidopa
  • Drug: levodopa/carbidopa
    entacapone + levodopa/carbidopa
Study Arms
  • Experimental: ODM-104
    Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days
    Intervention: Drug: ODM-104
  • Placebo Comparator: Placebo
    Oral capsules given once daily for one day or three times daily for 7 days
    Intervention: Drug: Placebo
  • Active Comparator: entacapone + levodopa/carbidopa
    entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day
    Interventions:
    • Drug: Entacapone
    • Drug: levodopa/carbidopa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2015)
101
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2013)
54
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects aged between 18 and 45 years
  • BMI 18-30 kg/m2
  • Weight 55-95kg
  • Written informed consent
  • Good General Health

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01840423
Other Study ID Numbers  ICMJE 3112001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Orion Corporation, Orion Pharma
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rainard Fuhr, MD Parexel
Study Director: angela ruck, PhD Orion Corporation, Orion Pharma
PRS Account Orion Corporation, Orion Pharma
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP