NL-OMON53911
Recruiting
Not Applicable
Safety, tolerability, pharmacokinetic and pharmacodynamic effects of single and multiple escalating doses of ODM-111 and effect of food on the pharmacokinetics of ODM-111 and pharmacokinetic drug-drug interaction potential of ODM-111 - FIMCARE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic-/neuropathic pain
- Sponsor
- Orion Corporation
- Enrollment
- 182
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following criteria to be included into the study:
- •1\. Written informed consent (IC) obtained
- •2\. Good general health ascertained by detailed medical history and laboratory
- •and physical examinations.
- •3\. Males and females between 18 and 55 years (inclusive).
- •4\. Body mass index (BMI) between 18\-32 kg/m2 (inclusive) (BMI \= weight/height2\).
- •5\. Weight 50\-120 kg (inclusive).
- •6\. Female participants with fertile male partner, and male participants with
- •female partners of child\-bearing potential, must adhere to a highly effective
- •form of contraception (e.g. combined or progestogen only hormonal
Exclusion Criteria
- •Subjects will not be included into this study if they meet any of the following
- •criteria: 1\. A predictable poor compliance or inability to understand and
- •comply with protocol requirements, instructions and protocol\-stated
- •restrictions or communicate well with the investigator 2\. Veins unsuitable for
- •repeated venipuncture or for cannulation. 3\. Evidence of clinically significant
- •cardiovascular, renal, hepatic, haematological, gastro\-intestinal, pulmonary,
- •immunologic, dermatologic, metabolic\-endocrine, neurological, urogenital,
- •psychiatric and/or other major disease as judged by the investigator. Any
- •surgical or medical condition (including cholecystectomy) which might
- •significantly alter the absorption, distribution, metabolism or excretion of
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study on the safety and effectiveness of the new investigational drug ODM-111 when given to healthy volunteers, and how ODM-111 is absorbed and processed by the human body.ovel treatment against chronic-/neuropathic pain.Nervous System DiseasesISRCTN84512888Orion Corporation (Finland)148
Completed
Not Applicable
Safety, tolerability, pharmacokinetic and pharmacodynamic effects of single and multiple escalating doses of ODM-108: a single centre study in healthy male volunteers.europathische pijn.Nerve damage pain.NL-OMON42514Orion Corporation Orion Pharma206
Active, not recruiting
Phase 1
A research study of how a new medicine NNC0365-3769 (Mim8) works in the body of healthy people and patients with bleeding disorderEUCTR2019-000465-20-ATovo Nordisk A/S94
Active, not recruiting
Phase 1
Safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple subcutaneous doses of NNC0365-3769 (Mim8) in healthy subjects and in subjects with haemophilia A with or without factor VIII inhibitors (NN7769-4513)severe haemophilia A with or without FVIII inhibitorsJPRN-jRCT2031200136Tsuchiyama Akio82
Active, not recruiting
Phase 1
A research study of how a new medicine NNC0365-3769 (Mim8) works in the body of healthy people and patients with bleeding disorderHealthy volunteers (Haemophilia A with or without inhibitors)Haemophilia AHaemophilia A with inhibitorsMedDRA version: 20.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2019-000465-20-GBovo Nordisk A/S82