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.

Phase 1

• Conditions: ovel treatment against chronic-/neuropathic pain.; Nervous System Diseases

• Registration Number: ISRCTN84512888
• Lead Sponsor: Orion Corporation (Finland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-25
• Last Update Posted: 7 November 2022
• Study Completion: 2023-12-06

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 148

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.
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 admission and during the stay at the study centre.
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:
15.1. QT c (calculated through the Fridericia’s formula) > 450 msec for male and > 470 msec for female subjects (If QTcinterval measured by the ECG machine algorithm is > 450/470 ms, 2 additional recordings will be done and mean QTcF value used to determine eligibility)
15.2. PR < 120 msec or > 200 msec
15.3. QRS < 70 msec or > 120 msec
15.4. 2° or 3° AV block
15.5. ventricular tachycardia
16. HR < 45 bpm or > 100

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The concentration of ODM-111 is measured throughout the 24 hours after dosing.

Secondary Outcome Measures

Name	Time	Method
Pain is measured using a VAS at several timepoints after dosing.