pijn nociceptive pain pain
Conditions
Interventions
period 1: GRT6005 600 microgram oral solution,
period 2: Fentanyl 3.5 microgram per kg bodyweight - Schedule A,
period 3: Fentanyl 3.5 microgram per kg bodyweight - Schedule B.
Sponsors
Grunenthal
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. White male subjects aged 18 years to 45 years inclusive. 2. Body mass index between 20 kg/m2 and 28 kg/m2 inclusive, with a body weight of not less than 50 kg. 3. Subjects must be in good health as determined by medical history, physical examination, 12-lead ECG, oxygen saturation, vital signs, and clinical laboratory parameters. 4. Subjects willing to use barrier contraception (condom) during sexual intercourse with women, and no sexual intercourse with women who are pregnant or lactating is allowed from dosing of GRT6005 until 1 month after the Final Examination. Subjects willing to ensure that their female sexual partner uses medically acceptable contraception during this time frame (e.g., oral contraceptive). 5. Subjects giving written informed consent to participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Resting pulse rate is 100 bpm after 5 min rest in semi-recumbent position. 2. Resting blood pressure after 5 min rest in semi-recumbent position: a. Systolic blood pressure is 150 mmHg. b. Diastolic blood pressure is 90 mmHg. 3. History of orthostatic hypotension. Standardization of trial population and safety. 4. Positive or missing test for human immunodeficiency virus antibodies (Type 1 and Type 2), hepatitis B surface antigens, hepatitis B core antigen antibodies, or hepatitis C virus antibodies. 5. Participation in another clinical trial within 90 days prior to enrollment into this trial. 6. Positive or missing drugs of abuse screening (alcohol breath test, urine screening test for drugs of abuse). 7. Diseases or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. 8. Marked repolarization abnormality (e.g., suspected or definite congenital long QT syndrome with QT and/or QTcB >500 ms or prolonged QTcB, i.e., >450 ms). 9. Bronchial asthma or other respiratory diseases. 10. Definite or suspected history of drug allergy or hypersensitivity. 11. Regular use of any medication at the time of enrollment and anticipated further use until first administration of IMP. 12. History of alcohol or drug abuse. 13. History of neurotic personality, psychiatric illness, or suicide risk. 14. Not able to abstain from consumption of: a. Beverages or food containing caffeine (tea, coffee, cola, chocolate, etc.) from 48 h prior to each dosing until discharge from the ward. b. Beverages or food containing quinine (bitter lemon, tonic water) from 2 weeks before dosing and during the whole trial. c. Grapefruit juice (sweet or sour) or alcohol from 48 h prior to each dosing until discharge from the ward. d. Poppy seed-containing beverages or food, from 72 h prior to enrollment and each dosing. 15. Blood loss of 500 mL within 3 months before enrollment into this trial, including blood donation. 16. History of or at risk of seizures (i.e., head trauma, epilepsy in family history, unclear loss of consciousness). 17. Known or suspected of not being able to comply with procedures described in the trial protocol. 18. Not able to communicate meaningfully with the Investigator and staff. 19. Smoking of >10 cigarettes/day or equivalent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory function (respiratory rate and oxygen saturation) using the dynamic end-tidal forcing technique (model for respiratory depression). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain test (pain detection threshold and pain tolerance) using an electrical pain test (transcutaneous electrical stimulation). Static pupillometry (pupil diameter). Ventilation (i.e., inspiratory volume per minute) using the dynamic end-tidal forcing technique. | — |
Countries
Netherlands
Outcome results
None listed