ademhaling en pijnstilling respiration
Conditions
Interventions
Pilot Phase (9 subjects - respiratory measurements and safety assessments):
After screening the subjects were allocated into 3 cohort groups. Each subject
received a single infusion of MR30365/07 on
Sponsors
Mundipharma Research Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy male subjects aged 18 to 45 inclusive. Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG. Normal lung function test (FEV1>85% of predicted normal value).
Exclusion criteria
Exclusion criteria: In the Investigator*s opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the screening visit. History of asthma, COPD, or other bronchial or lung diseases. History of regurgitation or difficulty of intubation. History of additional risk factors or Torsades de Pointes. Abnormal cardiac conditions (QTc Interval greater than 450msec at screening or pre-dose). Known sensitivity to fentanyl, opioids, ondansetron, naloxone, or related compounds.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pilot phase: To determine the MR30365/07 doses to be used in the main study based on respiratory responses and safety data Main phase: To obtain a dose-response relationship for MR30365/07*s analgesic and respiratory effects and compare these relationships with those of fentanyl and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pilot phase: To assess safety and tolerability of MR30365/07 Main phase: To assess safety and tolerability of MR30365/07 compared to fentanyl and placebo. To assess the PK of MR30365/07 and fentanyl | — |
Countries
Netherlands
Outcome results
None listed