Safety, tolerability, pharmacokinetic and pharmacodynamic effects of single and multiple escalating doses ofODM-111 and effect of food on the pharmacokinetics of ODM-111.

Orion Corporation (Finland)0 sites148 target enrollmentOctober 25, 2022

Conditionsovel treatment against chronic-/neuropathic pain.Nervous System Diseases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ovel treatment against chronic-/neuropathic pain.
Sponsor: Orion Corporation (Finland)
Enrollment: 148
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 25, 2022

End Date

December 6, 2023

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Orion Corporation (Finland)

Eligibility Criteria

Inclusion Criteria

•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).
•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), 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

•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 and Part III: Any current, clinically significant, known medical condition that would affect sensitivity to cold(such as atherosclerosis, Raynaud’s disease, urticaria, hypothyroidism) or pain
•5\. Part I: Intolerance of PainCart tests or tolerance at \> 80% of maximum input intensity for any pain test for cold.
•6\. Part III: Intolerance of PainCart tests or tolerance at \> 80% of maximum input intensity for any pain test for cold, pressure and electrical tests at the screening visit
•7\. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, 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 orcarbamazepin), 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 centre.
•10\. Use of nicotine\-containing products within 3 months before screening.