Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001100583
Ethics application status
Approved
Date submitted
13/10/2015
Date registered
20/10/2015
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a generic formulation of Inhaled Insulin against the innovators Humalog KwikPen for injection and the AFREZZA Inhalation Powder Cartridge conducted under fasting conditions in healthy male and female volunteers
Scientific title
A single dose, randomized, open label, pharmacokinetic and pharmacodynamic study of inhaled insulin in a 3 way crossover comparison against the innovators Humalog KwikPen for injection and the AFREZZA Inhalation Powder Cartridge conducted under fasting conditions in healthy male and female volunteers
Secondary ID [1] 287647 0
None
Universal Trial Number (UTN)
U1111-1174-8435
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetic and pharmacodynamic study conducted in healthy volunteers comparing three formulations of Insulin with no health condition or problem studied.

Insulin is a medicine that is used to lower blood glucose. 296478 0
Condition category
Condition code
Other 296737 296737 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the inhaled insulin (test) on one occasion and the innovator formulations of Humalog KwikPen (reference 1) on one occasion and Inhalation Powder cartridge (reference 2) on one occassion with each dose separated by a washout period of at least 2 days. The intervention for this trial is the test formulation of inhaled insulin.

Subject are allowed to sip water throughout each study period but are required not to eat for 10 hours before receiving each dose and to fast for approximately 8 hours after each dose. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored for 8 hours after dosing.

Each subject will receive a standard meal at about 8 hours after dosing in each study period with no additional food intake allowed. Alcohol breath testing, cotinine urine testing and checking of the subjects inhalation technique will be performed upon each participant reporting to the Clinical Site at least 12 hours prior to dosing.

Pre and post study laboratory, chest X-Ray, ECG, oximetry and spirometry tests will be completed to assess the health of participants along with HIV, Hepatitis, serum pregnancy, RPR and drugs of abuse testing.

The test and reference 2 dose will be inhaled using an inhaler. Each subject will be trained on the correct use of the inhaler using empty training devices.

To monitor glucose levels a glucose clamp technique will be employed to reduce the risk of hypoglycemia.

Due to the commercially sensitive nature of this study the Sponsor Company has requested that the doses to be administered are not disclosed.
Intervention code [1] 293047 0
Treatment: Drugs
Comparator / control treatment
Single dose, crossover study design whereby each participant receives the test formulation inhaled insulin on one occasion and the innovator formulations of Humalog KwikPen (reference 1) on one occasion and inhalation Powder Cartridge (reference 2) on one occasion with each dose separated by an at least 2 day washout period. The comparator/control for this trial is the innovator formulations of Insulin..
Control group
Active

Outcomes
Primary outcome [1] 296351 0
To compare the pharmacokinetic and pharmacodynamic parameters of insulin (as summarised by Cmax and AUC) for the three formulation. All serum samples will be assayed for insulin using one fully validated ELISA method. Validation will be conducted to comply with EU and FDA guidelines.
Timepoint [1] 296351 0
-30, -20, -10, 0, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 240, 360, 420 and 480 minutes after dosing
Secondary outcome [1] 318228 0
Time to maximum peak concentration (Tmax) will be determined by serum sample analysis. Tmax will be the time where the maximum concentration occurred in the sample points.
Timepoint [1] 318228 0
-30, -20, -10, 0, 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 180, 240, 360, 420 and 480 minutes after dosing

Eligibility
Key inclusion criteria
Healthy male and non-pregnant females
Aged between 18 and 55
Non-smoker
BMI between 18 and 30 inclusive
Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure, spirometry, oximetry, chest x-ray and laboratory tests
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history of recent recurrent attacks of bronchitis, COPD, emphysema, bronchitis, asthma, migraine headaches
Concomitant drug therapy of any kind
Sensitivity to insulin or any other similar class of medicines, or the excipients of insulin
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Females who are pregnant and/or are breastfeeding
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

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)
All formulations will be labelled as Formulation T, R1 or R2. The identification of each treatment will only be known to the Managing Director and the Section Head - Trials and Regulatory Affairs.

Each participant will be identified by a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number (randomisation number) after acceptance into the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation list will be prepared using a computer program for a balanced three-way crossover design.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2015
Actual
13/11/2015
Date of last participant enrolment
Anticipated
Actual
17/11/2015
Date of last data collection
Anticipated
Actual
10/12/2015
Sample size
Target
18
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 7228 0
New Zealand
State/province [1] 7228 0
Otago

Funding & Sponsors
Funding source category [1] 292213 0
Commercial sector/Industry
Name [1] 292213 0
Cipla Ltd
Country [1] 292213 0
India
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corp Ltd
Address
156 Frederick St
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 290888 0
None
Name [1] 290888 0
Address [1] 290888 0
Country [1] 290888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293682 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 293682 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 293682 0
New Zealand
Date submitted for ethics approval [1] 293682 0
24/09/2015
Approval date [1] 293682 0
23/10/2015
Ethics approval number [1] 293682 0
15/NTA/141

Summary
Brief summary
The objective of this study is to compare the rate and extent of absorption of inhaled insulin with the reference products, Humalog KiwikPen (reference 1) and Inhalation Powder Cartridge (reference 2) in healthy adult human subjects under fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60938 0
Dr Noelyn Hung
Address 60938 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin
9054
Country 60938 0
New Zealand
Phone 60938 0
+6434779669
Fax 60938 0
+6434779605
Email 60938 0
[email protected]
Contact person for public queries
Name 60939 0
Linda Folland
Address 60939 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin
9054
Country 60939 0
New Zealand
Phone 60939 0
+6434779669
Fax 60939 0
+6434779605
Email 60939 0
[email protected]
Contact person for scientific queries
Name 60940 0
Cheung-Tak Hung
Address 60940 0
Zenith Technology Corporation Limited
156 Frederick Street
Dunedin
9054
Country 60940 0
New Zealand
Phone 60940 0
+6434779669
Fax 60940 0
+6434779605
Email 60940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.