A study in healthy volunteers to understand the distribution of OX27 in the body

Active, not recruiting

• 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

Study Timeline

• Study Start: 2011-04-14
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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