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

Recruiting

• Conditions: Chronic-/neuropathic pain; 10029305

• Registration Number: NL-OMON53911
• Lead Sponsor: Orion Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 182

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part I and Part II: AEs, clinical and laboratory safety variables<br /><br>Part III: Drug-drug interaction potential<br /><br>Part IV: AE's, clinical and laboratory safety variables<br /><br>Part V: Drug-drug interaction potential</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part I and Part II: Pharmacokinetics Pharmacodynamics<br /><br>Part III: Pharmacokinetics, safety and tolerability of ODM-111<br /><br>Part IV: Safety and tolerability of ODM-111<br /><br>Part V: Safety and tolerability of ODM-111</p><br>