Pharmacokinetics and Bioavailability of a New Oral Analgesic: Fentanyl Wafer ('Waferyl' (TM)), in Healthy Volunteers.

Completed

• Conditions: Pain Management; Anaesthesiology - Pain management

• Registration Number: ACTRN12611000106932
• Lead Sponsor: iX Biopharma Pte Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1.Male or female aged between 18 and 45 years (inclusive).
2.Healthy volunteers – healthy volunteers are defined as individuals who are free from clinically significant illness or disease as determined by their medical/surgical history, physical examination (including height and weight), 12-lead ECG and clinical laboratory determinations.
3.Normotensive (systolic blood pressure (BP) between 90 mmHg and 140 mmHg, and diastolic BP between 60 mmHg and 90 mmHg).
4.Body Mass Index (BMI; calculated as weight [kg] / height [m2]) between 18 and 30 kg/m2.
5.HIV, Hepatitis B and Hepatitis C negative.
6.Adequate venous access in the left and right arm to allow collection of a number of blood samples.
7.Able to read and communicate in English with the Investigator and his/her staff.
8.Provide written informed consent to participate in the study and be willing to comply with the study procedures.
9. No abnormal finding of clinical relevance at the Screening evaluation.

Exclusion Criteria

1.Received or is anticipated to receive a new prescription systemic or topical medication within 14 days prior to the start of dosing or an over–the-counter medicine 48 hours prior to the start of dosing, with the exception of the contraceptive pill for female volunteers.
2.Known allergy or hypersensitivity reactions to naltrexone or fentanyl or other opioid analgesics (codeine, oxycodone, hydrocodone, morphine etc.),
3.History or evidence of drug abuse and/or positive urine drug test prior to start of the study.
4.Any condition that would interfere with drug absorption.
5.Abnormal laboratory test results deemed clinically significant by the Medical Officer (Principal Investigator or medically qualified nominee) within 28 days before enrolment.
6.As a result of medical review, physical examination (including height and weight) or Screening investigations, the Medical Officer considers the volunteer unfit for the study.
7.Positive alcohol breath test, which remains positive following one repeat.
8. Evidence of clinically relevant oral, cardiovascular, hematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, or skin disorder, or history of hypertension or heart disease.
9.Acute therapy for a serious infection within 30 days of study entry.
10.Currently suffers from clinically significant systemic allergic disease or has a history of significant drug allergies including a history of: anaphylactic reaction; allergic reaction due to any drug which leads to significant morbidity (e.g. penicillin); neuro malignant syndrome or malignant hyperthermia.
11.Have participated in a clinical trial or have received an experimental therapy within 30 days or 10 half-lives of the drug, whichever is the longer, prior to dosing.
12.Blood donation of greater than 400 mL within 8 weeks before the first dose administration.
13.Males who regularly drink more than four (4) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from alcohol during the 48 hours prior to dose administration and until completion of blood sampling.
14.Females who regularly drink more than two (2) units of alcohol daily (1 unit = 300 mL beer, 1 glass wine, 1 measure spirit) or those who may have difficulty abstaining from alcohol during the 48 hours prior to dose administration and until completion of blood sampling.
15.Positive serum pregnancy test at screening or a positive urine pregnancy test at check-in for female participants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate the pharmacokinetics and bioavailability of sublingual wafer fentanyl compared to intravenous fentanyl when administered to healthy male and female adult volunteers.[Sublingual Wafer - Blood samples taken at Predose, then 2, 5, 10, 15, 20, 30 and 45 minutes post-dose, then 1, 2, 3, 4, 6, 7, 8, 9, 10, 12, 16, 20 and 24 hours post-dose.<br><br>IV Fetanyl - Blood samples taken at Predose, then 3, 5, 7, 10, 15, 20, 25, 30 and 45 minutes post-dose, then 1, 2, 3, 6, 8, 10, 12, 16, 20 and 24 hours post-dose.]

Secondary Outcome Measures

Name	Time	Method
To investigate the sublingual acceptability of sublingual wafer fentanyl when given to healthy male and female adult volunteers.[Assessed via Likert Questionaire at 5, 10, 15, 30 and 60 minutes post-dose.]