Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000390583
Ethics application status
Approved
Date submitted
25/02/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Phase I, open-label, sequential-group, three-cohort study to evaluate the pharmacokinetic profile, the safety and the tolerability of a single injection of lanreotide Extended-Release Formulation (ERF) at doses of 120 mg and 240 mg in healthy volunteers
Scientific title
Phase I, open-label, sequential-group, three-cohort study to evaluate the pharmacokinetic profile, the safety and the tolerability of a single injection of lanreotide Extended-Release Formulation (ERF) at doses of 120 mg and 240 mg in healthy volunteers
Secondary ID [1] 311608 0
ASC-240-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 333029 0
Neuroendocrine Tumour 333030 0
Condition category
Condition code
Metabolic and Endocrine 329712 329712 0 0
Other endocrine disorders
Cancer 329713 329713 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort 1: 120mg Subcutaneous (SC) injection administered once, Lanreotide ERF injection administered by nurse at the clinical trial unit where the study is being conducted. The single injection is administered to the upper outer area of the buttock.
Cohort 2: 240mg Subcutaneous (SC) injection administered once, Lanreotide ERF injection administered by nurse at the clinical trial unit where the study is being conducted. The single injection is administered to the upper outer area of the buttock.
Cohort 3: 240mg Intramuscular (IM) Injection, administered once, Lanreotide ERF injection administered by nurse at the clinical trial unit where the study is being conducted. The single injection is administered to the upper outer area of the buttock.
Intervention code [1] 328061 0
Treatment: Drugs
Comparator / control treatment
120mg SC
Control group
Dose comparison

Outcomes
Primary outcome [1] 337509 0
The primary composite objective is to characterize the pharmacokinetic (PK) profile of a single deep subcutaneous (SC) injection of lanreotide Extended-Release Formulation (ERF) at the 240 mg dose in healthy volunteers (HV).
Timepoint [1] 337509 0
D1 to D28 and D1 to D56
Blood samples for PK assessment will be drawn at the following timepoints:
• Day 1: pre-dose, 1- 2-, 4-, 6-, 8-, 10- and 12-hours post-dose.
• Days 2, 3, 7, 10, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98 and 112 post-dose.

Secondary outcome [1] 432147 0
The full PK profiles of a single deep SC injection of lanreotide ERF at the 120 mg and 240 mg doses in Healthy Volunteers (HV).
Timepoint [1] 432147 0
• Day 1: pre-dose, 1- 2-, 4-, 6-, 8-, 10- and 12-hours post-dose.
• Days 2, 3, 7, 10, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98 and 112 post-dose.
Secondary outcome [2] 432148 0
The comparison of the full PK profiles of a single deep SC injection to a single intra-muscular (IM) injection of lanreotide ERF at the 240 mg dose in HV.
Timepoint [2] 432148 0
• Day 1: pre-dose, 1- 2-, 4-, 6-, 8-, 10- and 12-hours post-dose.
• Days 2, 3, 7, 10, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98 and 112 post-dose.
Secondary outcome [3] 432149 0
The safety of a single deep SC injection of lanreotide ERF at the 120 mg and 240 mg doses and of a single IM injection of lanreotide ERF at the 240 mg dose in HV.
Timepoint [3] 432149 0
From dosing, and continuously for the period of stay in the clinical unit. Then at each follow up visit until the end of the study. Days 0, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98 and 112 post-dose.
Secondary outcome [4] 432150 0
The tolerability of a single deep SC injection of lanreotide ERF at the 120 mg and 240 mg doses and of a single IM injection of lanreotide ERF at the 240 mg dose in HV at injection site.
Timepoint [4] 432150 0
post dose to day 112 (end of study). Conducted at each In-House and Post-Discharge Follow-up visit:
Day0, 1, 2, 4, 8, 14, 28, 56, 84, 112.

Eligibility
Key inclusion criteria
Subjects meeting the following criteria will be considered for inclusion into the study:
1. Subject must be willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.
2. Age 18–55 years (inclusive at the time of informed consent).
3. Females of childbearing potential must use acceptable double barrier contraceptive method from 28 days prior to dosing until at least 90 days after dosing. Acceptable methods include use of condoms for male partners, and the use of an effective contraceptive for the female subject that includes: oral contraceptive pills, long-acting implantable hormones, injectable hormones, vaginal ring or intrauterine device.
4. Non sterilized Mmales of childbearing potential must use an acceptable contraceptive method, including condoms, if sexually active with a female of childbearing potential.
5. Subjects must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and before administration of the initial dose of study drug.
6. Subjects must have a minimum body weight of 50 kg, and the body mass index (BMI) (expressed as weight [kg] / height [m2]) must be between greater than or equal 18 and less than 33 at Screening.
7. Subjects must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator.
8. Clinically acceptable supine blood pressure and pulse rate (systolic blood pressure between 90–140 mm Hg / diastolic blood pressure between 40-90 mm Hg / heart rate between 40–100 bpm) at Screening and Day -1.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A subject will not be eligible for inclusion if any of the following criteria applies during screening or prior to enrolment:
1. Inability or unwillingness to comply with study requirements.
2. Known thyroid disease, even if effectively euthyroid because of treatment.
3. Known hypersensitivity to any component of the study drug.
4. Planning for male subjects to donate sperm for at least 90 days after dosing with the study drug.
5. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator’s opinion, could adversely affect the safety of the subject.
6. Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will comply with the protocol or complete the study per protocol.
7. Any surgical or medical condition that could interfere with the absorption, distribution, metabolism or excretion of the study drug, including impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhoea.
8. Having undergone any major surgery during the 3 months prior to study drug administration.
9. Blood donation or significant blood loss (greater than or equal to 500mL) within 30 days prior to study drug administration.
10. Fever (body temperature greater than 38°C) or symptomatic viral or bacterial infection within 2 weeks prior to study drug administration.
11. Any acute illness within 30 days prior to study drug administration.
12. History of severe allergic or anaphylactic reactions.
13. Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis).
14. History of malignancy except for non-melanoma skin cancer excised more than 1 years prior to study drug administration.
15. Abnormal electrocardiogram (ECG) findings at Screening including PR greater than 220 msec, QRS greater than or equal to 120 msec, and QT interval corrected using Fridericia's correction (QTcF) greater than 450 msec, ST wave changes or any other abnormal findings that are considered by the Investigator to be clinically significant.
16. History or presence of a condition associated with significant immunosuppression.
17. Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical trial) within the 4 months prior to dosing or 5-half-lives, whichever is longer.
18. Positive test for hepatitis C (HCV) virus antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
19. Subjects with a positive urine drug screen test (including , amphetamines, methamphetamines, phencyclidine, barbiturate, methadone, tricyclic antidepressant, cocaine, opiates, cannabinoids and benzodiazepines) at Screening or Day -1.
20. Subjects with a history of substance abuse or dependency or history of recreational intravenous (IV) drug use over the last 2 years (by self-declaration).
21. Regular alcohol consumption defined as greater than 21 alcohol units per week for males, or greater than 14 units per week for females (where 1 unit equals 284 mL of beer, 25 mL of 40% spirit, or a 125 mL glass of wine).
22. Subjects unwilling to abstain from alcohol beginning 48 hours prior to admission to the Clinical Research Unit (CRU) and during the confinement period.
23. Regular consumption of stimulating beverages, defined as greater than5 coffees, teas, or coca cola drinks/ day or greater than 3 energy drinks/week.
24. Subjects unwilling to abstain from stimulating beverages consumption beginning 48 hours prior to admission to the CRU and during the confinement period.
25. Subjects who smoke greater than 10 cigarettes per week or equivalent use of nicotine-based products (including smoking tobacco, smokeless tobacco and nicotine patches) within 30 days prior to Screening.
26. Use of any IP or investigational medical device within 30 days prior to dosing or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to Screening.
27. Use of any prescription drugs, over the counter (OTC) medication, herbal remedies, supplements or vitamins within 7 days prior to dosing and during course of study without prior approval of the Investigator and Medical Monitor. Simple analgesia (paracetamol) may be permitted at the discretion of the Investigator. Oral contraceptives are permitted.
28. Subjects unwilling to refrain from strenuous exercise (including weightlifting) from the dosing day (Day 1) until completion of Day 7 visit.
29. Have received or plan to receive any vaccine within 7 days prior to dosing through to 7 days after dosing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/03/2024
Date of last participant enrolment
Anticipated
30/05/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
36
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315916 0
Commercial sector/Industry
Name [1] 315916 0
Ascil Australia Pty Ltd
Country [1] 315916 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ascil Australia
Address
Country
Australia
Secondary sponsor category [1] 318067 0
None
Name [1] 318067 0
none
Address [1] 318067 0
Country [1] 318067 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314762 0
Bellberry Human Research Ethics Committee K
Ethics committee address [1] 314762 0
https://bellberry.com.au/
Ethics committee country [1] 314762 0
Australia
Date submitted for ethics approval [1] 314762 0
25/01/2024
Approval date [1] 314762 0
19/02/2024
Ethics approval number [1] 314762 0

Summary
Brief summary
Study approved by bellberry ethics committee K on 19th February 2024.
This is a single-centre, single ascending dose study to assess the safety of lanreotide Extended-Release Formulation, and how this drug acts in the body in healthy volunteers. Lanreotide may be indicated for use in patients with neuroendocrine cancer, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed.

Who is it for?
You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study.
Participants who choose to enrol in this study may be enrolled into one of three dose cohorts. Healthy volunteer participants may receive either a single dose of lanreotide ERF administered as a subcutaneous (under the skin) injection or a single dose of lanreotide ERF administered as an intramuscular (into a muscle) injection. All participants will have their vital signs checked and will provide blood samples for testing.

It is hoped this research will determine the maximum dose and best injection method for lanreotide ERF that can be administered safely without causing severe reactions. Once the dose of lanreotide ERF has been determined in healthy volunteers, a trial investigating the efficacy of lanreotide ERF as a treatment for neuroendocrine cancer patients may proceed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132646 0
Dr Kristi McLendon
Address 132646 0
Q-Pharm Pty Ltd Level 5, CBCRC , 300C Herston Rd Herston QLD 4006
Country 132646 0
Australia
Phone 132646 0
+61 1800243733
Fax 132646 0
Email 132646 0
k.mclendon@nucleusnetwork.com.au
Contact person for public queries
Name 132647 0
Sam Vohra
Address 132647 0
Avion Medical Pty Ltd, level 1, 10 Oxley road, Hawthorn,VIC, 3122
Country 132647 0
Australia
Phone 132647 0
+61 450556969
Fax 132647 0
Email 132647 0
sam@avionmedical.com.au
Contact person for scientific queries
Name 132648 0
Sam Vohra
Address 132648 0
Avion Medical Pty Ltd, level 1, 10 Oxley road, Hawthorn,VIC, 3122
Country 132648 0
Australia
Phone 132648 0
+61 450556969
Fax 132648 0
Email 132648 0
sam@avionmedical.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.