A Randomized, double-blind Crossover Trial to Investigate the Effects of Oliceridine and Morphine on Ventilatory Drive and Pain Relief in Healthy Elderly Subjects * a population pharmacokinetic/pharmacodynamic modeling study

Completed

• Conditions: pijnbestrijding; pain; postoperative pain

• Registration Number: NL-OMON50904
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-11
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Absence of any significant medical, neurologic, or psychiatric illness as
determined by the investigators.
- Age 55 yr or older;
- Body mass index (BMI) of 19 - 35 kg/m2. The BMI range is relatively large to
obtain a representative sample of individuals in the population.
- Willingness and competence to sign written informed consent.
- Screening cold pressor test hand removal latencies of > 20 and < 120 seconds.

Exclusion Criteria

1. Clinically significant medical, surgical, psychiatric or substance abuse
condition or history of such condition that would confound the interpretation
of data in the study.
2. Clinically significant, immune mediated hypersensitivity reaction or
intolerance to opioids.
3. Exposure to opioids or anesthesia within 30 days before the first treatment
period of the study.
4. Caffeine within 24 hours before the first treatment period of the study.
5. Positive urine drug screen or alcohol breathalyzer test at the screening
visit or positive urine dipstick for substances of abuse or alcohol breath test
at each visit.
6. Participation in a previous oliceridine clinical study.
7. Participation in another interventional clinical study within 30 days before
the first treatment period of the study.
8. Weight < 50 kg.
9. Body mass index outside the range of 18 * 35 kg/m2, inclusive.
10. Cytochrome P450 (CYP450) 2D6 poor metabolizer (PM) status or indeterminate
results for 2D6 genotype and/or phenotype.
11. Any clinically significant clinical laboratory abnormality, including total
bilirubin > 2 × upper limit of normal [ULN] or elevated hepatic transaminases
(aspartate aminotransferase [AST] > 1.5 × ULN OR alanine aminotransferase [ALT]
> 1.5 × ULN).
12. Clinically significant abnormality on electrocardiogram, including a QT
interval corrected for heart rate (QTcF interval) of > 450 milliseconds, at the
screening visit.
13. Clinically significant, immune mediated hypersensitivity reaction or
intolerance to 5-HT3 inhibitors.
14. Unsuitable screening HCVR test results (e.g., ability to tolerate the mask,
breathe in a regular fashion, increase ventilation in response to increases in
inhaled CO2), as judged by the investigator
15. A high risk of obstructive sleep apnea as determined by the STOP-BANG
questionnaire (score greater than 4);
16. Alcohol intake of more than 4 units/day or more than 28 units/week;
17. The short version of the Mini Mental State Examination with a score less
than 8. The latter exclusion criterion was to prevent that subjects with some
form of cognitive impairment participated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Hypercapnic ventilatory response; Pain relief and plasma concentrations<br /><br>oliceridine and morphine. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Nausea, vomiting, sedation, dizziness, lightheadedness, drug likability. </p><br>