- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055936
Dose-finding Pharmacokinetic Study in Healthy Males (COMDOS1)
May 3, 2021 updated by: Orion Corporation, Orion Pharma
A Dose-finding Study for Levodopa, Carbidopa and ODM-104 Test Formulations After Repeated Administration in Healthy Males
This is a phase I PK study in healthy males.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a phase I, open, repeated dose, randomised PK study in healthy males.
The study will consist of 4 parallel groups (Groups 1-4).
All groups will have a crossover design with 4 treatment periods, each lasting for 7 days.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Neu-Ulm, Germany, 89231
- Nuvisan Pharma Services
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Written informed consent (IC) obtained.
- Good general health ascertained by detailed medical history and physical examinations.
- Males between 18-65 years of age inclusive at screening.
- Body mass index (BMI) between 19-30 kg/m2 (BMI = weight/height2) inclusive at screening.
- Weight at least 55 kg inclusive at screening.
- Regular intestinal transit (no recent history of recurrent constipation, diarrhoea, or other intestinal problems, and no history of major gastrointestinal surgery).
- Subject with a partner of childbearing potential agrees to use adequate contraception from the first dose of study treatment until 90 days after the last dose of study treatment. Adequate methods of contraception include: Hormonal contraceptives, barrier methods (condom, diaphragm, cervical cap, etc.) in combination with a spermicide, intrauterine device and sexual abstinence.
- Subject agrees to not donate sperm from the first dose of study treatment until 90 days after the last dose of study treatment.
Exclusion Criteria:
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease or cancer (except local non-melanoma skin cancer) within the previous 2 years.
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol for occasional pain is allowed.
- Any clinically significant abnormal laboratory value or ECG (such as prolonged QTcF >450 ms or QRS >120 ms) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he takes part in the study.
- Known hypersensitivity to the active substances or the excipients of the drugs.
- History of vasovagal collapses or vagal reactions with unexplained reason within the previous 2 years or a tendency for vasovagal reactions during blood sampling.
- HR < 50 bpm or > 90 bpm in the supine position after 5 min rest at the screening visit.
At the screening visit:
- systolic BP < 100 mmHg or > 140 mmHg in the supine position after 5 min rest
- diastolic BP < 50 mmHg or > 90 mmHg in the supine position after 5 min rest.
- Creatinine > 1.5 x upper limit of normal (ULN) and alanine aminotransferase or aspartate aminotransferase >1.25 x ULN at screening.
- History of anaphylactic/anaphylactoid reactions.
- Strong tendency to motion sickness.
- Recent or current (suspected) drug abuse.
- Recent or current alcohol abuse; regular drinking of more than 21 units per week (1 unit = 4 cl spirits or equivalent).
- Current use of nicotine-containing products more than 5 cigarettes (or equivalent)/day and/or inability to refrain from the use of nicotine-containing products for 48 h before the first dose in each period until collection of the 24 h PK sample in the morning of day 8.
- Use of caffeine-containing beverages more than 600 mg of caffeine/day and/or inability to refrain from using caffeine-containing beverages 24 h before the first levodopa administration on the PK day (day 7) until collection of the 24 h PK sample in the morning of day 8.
- Blood donation or loss of a significant amount of blood (> 500 ml) within 90 days before the first study treatment administration.
- Participation in another investigational drug study or administration of another investigational drug within 60 days before the first study treatment administration.
- Veins unsuitable for repeated venipuncture or cannulation.
- Predictable poor compliance or inability to communicate well with the study centre personnel.
- Inability to participate in all treatment periods.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A1
levodopa 50 mg, carbidopa 12.5 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
|
Experimental: B1
levodopa 50 mg, carbidopa 65 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
|
Experimental: C1
levodopa 50 mg, carbidopa 65 mg, ODM-104 50 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104 50 mg or 100 mg
|
Experimental: D1
levodopa 50 mg, carbidopa 65 mg, ODM-104 100 mg A4 ; B4 l; C4 ; D4 levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104 50 mg or 100 mg
|
Experimental: A2
levodopa 100 mg, carbidopa 25 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
|
Experimental: B2
levodopa 100 mg, carbidopa 65 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
|
Experimental: C2
levodopa 100 mg, carbidopa 65 mg, ODM-104 50 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104 50 mg or 100 mg
|
Experimental: D2
levodopa 100 mg, carbidopa 37,5 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
|
Experimental: A3
levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104 50 mg or 100 mg
|
Experimental: B3
levodopa 150 mg, carbidopa 65 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
|
Experimental: C3
levodopa 150 mg, carbidopa 65 mg, ODM-104 50 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104 50 mg or 100 mg
|
Experimental: D3
levodopa 150 mg, carbidopa 65 mg, ODM-104 100 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104 50 mg or 100 mg
|
Experimental: A4
levodopa IR 100 mg (Sinemet), carbidopa 25 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
|
Experimental: B4
levodopa 100 mg, carbidopa 65 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
|
Experimental: C4
levodopa 100 mg, carbidopa 25 mg, ODM-104 100 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104 50 mg or 100 mg
|
Experimental: D4
levodopa 100 mg, carbidopa 65 mg, ODM-104 100 mg
|
Levodopa 50 mg or 100 mg or 150 mg
Other Names:
Carbidopa 12.5 mg or 25 mg or 65 mg
ODM-104 50 mg or 100 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24)
Time Frame: During 24 hours
|
Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24)
|
During 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fluctuation of Levodopa Cmax/Cmin, Tau
Time Frame: 16 hours
|
Explore fluctuation of levodopa Cmax/Cmin, tau.
Figures given are per performed statistical analysis.
|
16 hours
|
Levodopa Peak Plasma Concentration (Cmax)
Time Frame: 24 hours
|
Levodopa peak plasma concentration (Cmax)
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Denis Strugala, DR.med., Nuvisan GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 21, 2017
Primary Completion (Actual)
June 9, 2017
Study Completion (Actual)
June 9, 2017
Study Registration Dates
First Submitted
January 20, 2017
First Submitted That Met QC Criteria
February 14, 2017
First Posted (Actual)
February 16, 2017
Study Record Updates
Last Update Posted (Actual)
May 27, 2021
Last Update Submitted That Met QC Criteria
May 3, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3112005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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