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Trial registered on ANZCTR


Registration number
ACTRN12611000106932
Ethics application status
Approved
Date submitted
14/01/2011
Date registered
1/02/2011
Date last updated
1/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pharmacokinetics and Bioavailability of a New Oral Analgesic: Fentanyl Wafer ('Waferyl' (TM)), in Healthy Volunteers.
Scientific title
Pharmacokinetics and Bioavailability of a New Sublingual
Fentanyl Wafer (Waferyl (TM)) in Healthy Volunteers.
Secondary ID [1] 253417 0
IXB001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain Management 260963 0
Condition category
Condition code
Anaesthesiology 259100 259100 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sublingual Fetanyl Wafer.

In the present cross-over trial, healthy participants will receive a single dose of both sublingual wafer (100mcg) and IV fentanyl (100mcg), one treatment per period, in randomised order. A 5 day wash-out period is applicable between Sublingual/IV treatment arms.

In both arms dosing is subject to participants' passing a 50mg pre dose-day (Day -1) naltrexone challenge, such that pre-dose naltrexone may be administered to counter-act the effects of fetanyl dosing.
Intervention code [1] 257862 0
Treatment: Drugs
Comparator / control treatment
IV Fentanyl

Single Intravenous dose of 100mcg administered as a 5 minute direct infusion (via an indwelling cannula) at the commencement of Day 1 of the study.
Control group
Active

Outcomes
Primary outcome [1] 261950 0
To investigate the pharmacokinetics and bioavailability of sublingual wafer fentanyl compared to intravenous fentanyl when administered to healthy male and female adult volunteers.
Timepoint [1] 261950 0
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.

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 [1] 268863 0
To investigate the sublingual acceptability of sublingual wafer fentanyl when given to healthy male and female adult volunteers.
Timepoint [1] 268863 0
Assessed via Likert Questionaire at 5, 10, 15, 30 and 60 minutes post-dose.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Inclusion / Exclusion criteria will be assessed by the clinical sites. Eligible participant will be enrolled according to a randomisation schedule provided to the Sites.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualified personnel created a computer program to generate the randomisation schedule for sequence assignment.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258329 0
Commercial sector/Industry
Name [1] 258329 0
iX Biopharma Pte Ltd
Address [1] 258329 0
77 High Street, Suite 0311/12
High Street Plaza,
Singapore 179433
Country [1] 258329 0
Singapore
Primary sponsor type
Commercial sector/Industry
Name
iX Biopharma Pte Ltd
Address
77 High Street, Suite 0311/12
High Street Plaza,
Singapore 179433
Country
Singapore
Secondary sponsor category [1] 257486 0
None
Name [1] 257486 0
Address [1] 257486 0
Country [1] 257486 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260308 0
Bellberry Ethics Committee
Ethics committee address [1] 260308 0
229 Greenhill Road
Dulwich SA 5065
Phone: 08 8361 3222
Fax: 08 8361 3322
Ethics committee country [1] 260308 0
Australia
Date submitted for ethics approval [1] 260308 0
Approval date [1] 260308 0
25/11/2010
Ethics approval number [1] 260308 0
2010-07-044

Summary
Brief summary
Fentanyl is a strong analgesic (painkiller) with similar effects to morphine. Recently a fentanyl wafer has been developed that dissolves quickly when placed under the tongue. This has advantages of quick absorption, rapid onset of action and would be suitable for patients who cannot swallow tablets, or are phobic to needles.

The present study compares the pharmacokinetics and bioavailability of the sublingual wafer fetanyl formulation with the currently registered IV forumulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32094 0
Address 32094 0
Country 32094 0
Phone 32094 0
Fax 32094 0
Email 32094 0
Contact person for public queries
Name 15341 0
Cameron Johnson
Address 15341 0
Linear Clinical Research
Level 1, Hospital Avenue, Nedlands
Perth, WA 6009
Country 15341 0
Australia
Phone 15341 0
+61 8 6382 5100
Fax 15341 0
Email 15341 0
cjohnson@linear.org.au
Contact person for scientific queries
Name 6269 0
Cameron Johnson
Address 6269 0
Linear Clinical Research
Level 1, Hospital Avenue, Nedlands
Perth, WA 6009
Country 6269 0
Australia
Phone 6269 0
+61 8 6382 5100
Fax 6269 0
Email 6269 0
cjohnson@linear.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary