E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Not applicable - healthy volunteers |
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E.1.1.1 | Medical condition in easily understood language |
Not applicable - healthy volunteers |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 22.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10022891 |
E.1.2 | Term | Investigations |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the absolute bioavailability of intranasal sufentanil/ketamine in a standardized study set-up with healthy volunteers |
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E.2.2 | Secondary objectives of the trial |
To assess the pharmacokinetic profile and safety of intranasal administration of sufentanil/ketamine |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
i) Healthy volunteers; male ii) Age from 18 up to 55 years iii) Non-smokers iv) Body mass index (BMI) from 18.5 kg/m2 up to 30 kg/m2 v) Categorized as ASA Physical Status Class 1 or 2 vi) Clinically normal medical history, physical findings, vital signs, ECG and laboratory values as judged by the investigator at the time of the screening visit. A potential participant with measurements outside of the reference range for the population being studied may be included at the investigator´s discretion provided the finding is unlikely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedures. vii) The potential participant gives written informed consent for participation in the study |
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E.4 | Principal exclusion criteria |
i)Current or history of any clinically significant disease or disorder, which, in the opinion of the investigator, may put the potential participant at risk when participating in the study, or influence the potential participant’s ability to participate in the study or influence the study results. ii.) Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedure iii.) Mental illness iv.) Opioid Risk Tool score of >3 v.) Pain Catastrophizing Scale score, total points >30 vi.) Hospital Anxiety and Depression Scale (HADS), points ≥11 for anxiety or ≥11 points for depression vii.) Daily intake of analgesics viii.) History of alcohol or drug abuse or use of illicit drugs Positive screen for drugs of abuse at screening or on admission to the Clinic prior to the administration of investigational product. ix.) Use of prescription drugs within 14 days or over-the-counter drugs 24 hours (intranasal medication 48 hours) prior to the first dose of study medication, unless it is the opinion of the Investigator that the medication will not interfere with the study procedures or compromise participant x.) Participants who have planned any scheduled invasive treatment or medical/surgical procedure during the study period xi.) Participant showing abnormal nasal cavity/airway such as: a. major septal deviation b. evidence of previous nasal disease, surgery, and dependence of inhaled drug c. current significant nasal congestion due to common cold d. minimum air flow during each nasal passage xii.) History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation xiii.) Positive tests for HIV, hepatitis B and hepatitis C xiv.) Positive COVID-19 test or clinical symptoms of COVID-19 (testing of participants will follow the health authorities’ guidelines and current guidelines for the Capital Region of Denmark) xv.) Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent for this trial xvi.) Blood donation within 4 weeks prior to the first dosing visit |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetic parameters maximal plasma concentrations (Cmax), area under the curve representing total drug exposure (AUC(0-t)), determined by the plasma concentration data of analytes |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Pharmacokinetic parameters elimination half-lives (T½), clearance (CL), volume of distribution (V), determined by the plasma concentration data of analytes.
-Safety |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0-48 hours post dosing
Safety will be evaluated during the whole study period until 48 hours after last dose. Vital signs will be continuously monitored and observed post administration until discharge. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |