The effect of cebranopadol, oxycodone, and placebo on respiration, the central nervous system, and pain perceptio

Phase 1

• Conditions: Ventilatory drive, central nervous system and pain in healthy subjects; Not Applicable

• Registration Number: ISRCTN11320277
• Lead Sponsor: Park Therapeutics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-27
• Last Update Posted: 15 August 2022
• Study Completion: 2023-05-25

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Signed informed consent prior to any study-mandated procedure.
2. Subject is able to speak, read, and understand Dutch and voluntarily provide written informed consent to participate in the study.
3. Adult men or women aged 18?to?45?years, inclusive.
4. Subjects are in good health as indicated by medical history, physical examination, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG.
5. Body mass index between?18.0?kg/m2?and 32.0?kg/m2?and body weight greater than?50?kg,?inclusive.
6. Adequate contraception is being used or women of nonchildbearing potential may be enrolled if surgically sterile (i.e.,?after hysterectomy) or postmenopausal for at least 2?years (based on subject’s report).
• For women of childbearing potential:
- A medically acceptable and highly effective method of birth control is defined as any form of contraception with a low failure rate defined as <1% per year.
- For example:
• Hormonal contraceptives for at least 8?weeks prior to?screening?and at least until 4?weeks after the?Follow-up visit.
• An intra-uterine device.
• Additional barrier contraception should be used by the partner for the duration of the trial, defined as from the time of?screening?until 4?weeks after the?follow-up visit. A single barrier method alone is not acceptable.
• For men:
- Subjects must be willing to use medically acceptable and highly effective methods of birth control. Subjects must be willing to use barrier contraception (condom) during sexual intercourse with females from the first administration of IMP until 4?weeks after the?Follow-up visit.
- Subjects must be willing to take care that their female sexual partner uses at least 1?additional method of contraception with a low failure rate defined as <1% per year (e.g.,?hormonal contraceptives, diaphragm) during this time

Exclusion Criteria

1. History or presence of clinically significant cardiovascular?(incl. a history of risk factors for torsade de pointes e.g., heart failure, hypokalaemia, family history of long QT syndrome, history of myocardial infarction, ischaemic heart disease, clinically significant arrhythmia or uncontrolled arrhythmia or cardiac failure), pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease(e.g., anxiety); or any other condition (e.g., hyperventilation disorder), which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results.
2. History of known difficult airway access or uncontrolled gastroesophageal reflux disease (GERD), gastric motility disorders, or delayed gastric emptying
3. Has?clinically significant?abnormalities?on ECG?at screening or Day -1,?as defined by the following:
a. prolonged corrected QT interval (Fridericia-corrected QT interval [QTcF] > 450ms?in males and >470 ms in females) demonstrated?on ECG;
b. Left bundle branch block at Screening or Baseline
4. Systolic blood pressure (BP) >150 or <90 mmHg or diastolic BP >95 or <50 mmHg at Screening or Baseline, or history of clinically significant orthostatic hypotension.
5. Heart rate (HR) <40 beats per minute (bpm) or >100 bpm?at Screening.
6. Is currently enrolled in another clinical study or used any investigational drug or device within 3 months prior to dosing or has participated in more than 4 investigational drug studies within 1 year prior to Screening.
7. Has any condition in which an opioid is contraindicated (e.g.,?significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or has or is suspected of having paralytic ileus).
8. Have a history of chronic obstructive pulmonary disease or any other lung disease (e.g.,?asthma, bronchitis, obstructive sleep?apnoea, exercise-induced asthma) that would cause CO2?retention.
9. History of opioid use disorder per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) classification, or other drug/substance or alcohol dependency or abuse?(excluding nicotine and caffeine) within the last 5?years?before Screening,?which, in the opinion of the Investigator, would jeopardize the safety of the subject or the validity of the study results
10. Has a positive?alcohol test or?urine drug screen for drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine and opioids)?at Screening or?Day -1.
11. Use of nicotine-containing products within 4 weeks before the Screening visit and not able to withhold from smoking during the study.
12. Pregnant or breastfeeding.
13. Subjects indicating pain test intolerability at Screening or achieving pain tolerance at >80% of maximum input intensity for the pain tests.
14. Demonstrated allergic reactions (e.g., food, drug, atopic reactions, or asthmatic episodes) which, in the opinion of the Investigator, interfere with the subject’s ability to participate in the trial.
15. Positive hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (Anti-HBc), hepatitis C antibodies (HCV Ab), or human immunodeficiency virus an

Study & Design

• Study Type: Interventional
• Study Design: Not specified