Chronic-/neuropathic pain
Conditions
Interventions
ODM-111
Losartan, omeprazole, dextromethorphan, midazolam, rosuvastatin, dabigatran
Sponsors
Orion Corporation
Eligibility
Age
18 Years to 64 Years
Inclusion 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 contraceptives associated with inhibition of ovulation, intrauterine devices or intrauterine hormone-releasing system; for Part III and Part V, all combined with a male or female condom with diaphragm, sponge or cervical cap), if sexually active and not permanently sterilised, for females from 4 weeks before the first study treatment administration, and for males from admission to study centre until 3 months after the end-of-study visit. Additionally, women who are postmenopausal (1 year since last menstrual cycle) are considered not to be reproductive and can be included. For male subjects, sperm donation is not allowed until 3 months after the end-of-study visit.
Exclusion criteria
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 any drug. 4. Part I: Any current, clinically significant, known medical condition that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (i.e., disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy). 5. Part I: Intolerance of PainCart tests or tolerance at > 80% of maximum input intensity for any pain test for cold. 6. Obsolete exclusion criteria removed in Amendment 5. 7. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, (in Part III allergic reactions against losartan, omeprazole, dextromethorphan or midazolam and in Part V dabigatran etexilate and rosuvastatin) or multiple drug allergies (non-active hay fever is acceptable). 8. Intake of any medication that could affect the outcome of the study, as judged by the investigator, within 2 weeks before the first study treatment administration (1 month for enzyme inducing drugs like rifampicin or carbamazepin), 4 weeks for live vaccines and 2 weeks for other vaccines including COVID-19 vaccines. 9. A history of alcoholism or current excess alcohol intake (including regular consumption of more than 2 units daily on average [1 unit = approximately 250 ml of beer, 100 ml of wine, or 35 m of spirits]); inability to refrain from the intake of alcohol from 48 h before the first study treatment administration and during the stay at the study site (Part I, Part II and Part IV) and during the Part III until Day 17 and during the Part V until Day 22. 10. Part I : Use of nicotine-containing products within 3 months before screening. Part II-Part V: Current use of nicotine-containing products on a daily basis. 11. Inability to refrain from using nicotine-containing products during the stay at the study centre. 12. History of drug abuse within 2 years or positive drug screen at screening. 13. Inability to refrain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) before the first study treatment administration and during the stay at the study site. 14. Blood donation or loss of significant amount of blood (>= 500 ml) within 3 months before the admission to study centre. 15. Abnormal 12-lead ECG finding of clinical relevance at the screening visit, (after 5 min rest in supine position, confirmed by a repeat measurement) for example: • QTc (calculated through the Fridericia*s formula) > 450 msec for male and > 470 msec for female subjects (If QTc interval measured by the ECG machine algorithm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part I and Part II: AEs, clinical and laboratory safety variables Part III: Drug-drug interaction potential Part IV: AE's, clinical and laboratory safety variables Part V: Drug-drug interaction potential | — |
Secondary
| Measure | Time frame |
|---|---|
| Part I and Part II: Pharmacokinetics Pharmacodynamics Part III: Pharmacokinetics, safety and tolerability of ODM-111 Part IV: Safety and tolerability of ODM-111 Part V: Safety and tolerability of ODM-111 | — |
Countries
Netherlands
Outcome results
None listed