A study in healthy volunteers to understand the distribution of OX27 in the body
- Conditions
- Healthy volunteers (Treament of breakthrough pain)Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2011-001325-25-SE
- Lead Sponsor
- Orexo AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Signed informed consent obtained before any trial procedures
2. Healthy male or female volunteer, 18–55 years of age (inclusive), with suitable veins for cannulation or repeated venipuncture
3. Vital signs: pulse within 45–90 bpm, systolic blood pressure within 90–140 mmHg, diastolic blood pressure within 50–90 mmHg (extremes included)
Are the trial subjects under 18? no
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Weight outside normal, i.e., body mass index (BMI) not within 18.5–30 kg/m2 (inclusive)
2. Daily use of nicotine products within six months before the first dose of OX27 (Occasional smoking is allowed, but not usage of snuff or substitute for snuff).
3. Any intake of alcohol within 72 hours before Day -1 of Visit 2
4. Any drug abuse according to drug screen tests
5. Hepatitis B or C according to diagnostic tests
6. HIV according to diagnostic test
7. Use of prescription medication (except oral contraceptives), over-the-counter (OTC) medication or herbal remedies within 14 days before Day -1 of Visit 2, or within five half-lives of the drug, whichever is longer
8. Use of CYP3A4 substrates, inducers or inhibitors within 2 weeks before Day -1 of Visit 2 or during the trial (other than those administered as part of the trial)
9. Ingestion of grapefruit or grapefruit juice within 72 hours before Day -1 of Visit 2
10. Any known hypersensitivity to sufentanil, naltrexone or other opioids
11. Pregnant or breastfeeding woman or woman not using adequate birth control (e.g., intrauterine device, barrier method, per oral contraceptive, hormone injection or implants)
12. Participation in any other clinical trial and/or intake of any investigational drug within 30 days (or five half-lives of the drug, whichever is longer) before Visit 1
13. In the Investigator’s judgement, clinically significant abnormalities at the screening examination or in the laboratory test results
14. Donation of blood or plasma to a blood bank or in a clinical trial (except Visit 1) within 3 months before
screening
15. Any history of drug or alcohol abuse
16. Clinically significant lung disease as judged by the Investigator, or sleep apnoea, or narcolepsy
17. Clinically significant ECG abnormalities or arrhythmia at screening or on Day -1 (at Visit 2) as judged by the Investigator
18. Any symptom of infection within 6 days before first dose of OX27
19. Subject has any disease affecting the oral cavity that may affect the sublingual mucosa, for example Candida Albicans or any pre-existing oral mucosal lesion
20. Any use of dental whitening treatments within 1 week prior to first OX27 administration (whitening toothpaste is allowed)
21. Subject has oral pathology or dental devices, which may affect absorption from the sublingual space
22. Subject has current piercings of tongue or lip (historical piercings that are completely healed are acceptable)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - To evaluate the pharmacokinetics of 40 µg sublingual OX27 tablets when single and repeated doses are administered to healthy subjects.<br>- To evaluate the pharmacokinetics of three different 20 µg sublingual OX27 tablet formulations when single doses are administered to healthy subjects<br>;Secondary Objective: To evaluate if there is a time dependency during repeated dosing of sublingual OX27 tablets in healthy subjects. <br>- To assess local tolerability of single doses and repeated doses of sublingual OX27 tablets in healthy subjects. <br>- To assess taste of each tablet formulation of sublingual OX27. <br>- To assess subject safety and tolerability of sublingual OX27 under naltrexone blockade.<br>;Primary end point(s): Cmax , AUC0-inf , Cmax,ss and AUCt,ss;Timepoint(s) of evaluation of this end point: Endpoints based on plasma concentration measures during the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Tfirst, Tmax , AUC0-t, T½, Cl/F, VZ/F, Cfirst and ?z <br>- Tmax,ss, Cav, T½,ss, Clss/F, accumulation ratio (ratios of AUCt,ss to AUCt <br>and Cmax,ss to Cmax) AUCt,ss/AUC0-inf, VZss/F and Ctrough before each dose, AUC0-tmax (Treatment arm B only)<br>- Visual review of the sublingual mucosa. <br>- Adverse events, clinical chemistry, ECG, telemetry, respiratory rate, blood pressure and arterial oxygen saturation measured by pulse oximetry.;Timepoint(s) of evaluation of this end point: measures during the study. AE and vital signs are emasures throughout the study.