Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000386730
Ethics application status
Approved
Date submitted
8/04/2013
Date registered
10/04/2013
Date last updated
23/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety, tolerability, food effect and pharmacokinetics of FT011 in healthy volunteers and patients with Type 2 diabetes-associated diabetic nephropathy
Scientific title
A Phase I, double blind, randomised, placebo-controlled, dose-escalating study of the safety, tolerability, food effect and pharmacokinetics of single and repeat doses of FT011 administered orally to healthy volunteers and patients with diabetic nephropathy associated with Type 2 diabetes
Secondary ID [1] 282248 0
Protocol number FT011-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic nephropathy 288774 0
Condition category
Condition code
Renal and Urogenital 289126 289126 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FT011 oral capsules.

Part A: 5 sequential cohorts of healthy volunteers each receiving a single dose of 10, 30, 100, 300 or 1000mg and followed up to Day 7.

Part B: single cohort of healthy volunteers receiving a single dose of 100mg in the fed or fasted state followed by 10 day washout then crossover to a single dose of 100mg in the alternate state. E.g a subject may be randomised to receive the dose while fasted, then will return to receive a dose after a meal, or vice versa. Subjects will be followed up to Day 7 after the second dose. Part B may run concurrently with Part A, once Part A 100mg cohort is complete.

Part C: 3 cohorts of healthy volunteers followed by 2 cohorts of patients each receiving one dose per day for 14 days, and followed up to Day 21. Dose levels to be determined after Part A is complete. Part C will run after Part A and Part B are complete and safety and dose levels have been reviewed.

All subjects (Parts A, B and C) will be resident in clinic for dosing. This will ensure dosing compliance.

In each cohort 75% of subjects will receive FT011 and 25% will recieve placebo
Intervention code [1] 286867 0
Treatment: Drugs
Comparator / control treatment
Placebo oral capsules containing microcrystalline cellulose.

As this is a blinded study dosing periods and times will be the same as for subjects receiving FT011.

In each cohort 25% of subjects will receive placebo and 75% will receive FT011
Control group
Placebo

Outcomes
Primary outcome [1] 289242 0
Safety and tolerability of a single dose of FT011 in healthy volunteers (Part A) as assessed by vital signs, medical history, physical examination, laboratory evaluations, 12-lead ECG), evaluation of adverse events and concomitant medications.
Timepoint [1] 289242 0
Monitored and recorded until 7 days post dose
Primary outcome [2] 289243 0
Safety and tolerability of a single dose of FT011 in healthy volunteers in the fed and fasted state (Part B) as assessed by vital signs, medical history, physical examination, laboratory evaluations, 12-lead ECG), evaluation of adverse events and concomitant medications.
Timepoint [2] 289243 0
Monitored and recorded until 7 days post dose in each state (fed or fasted)
Primary outcome [3] 289244 0
Safety and tolerability of repeat doses of FT011 when administered to healthy volunteers and Type 2 diabetic patients with DN (Part C) as assessed by vital signs, medical history, physical examination, laboratory evaluations, 12-lead ECG), evaluation of adverse events and concomitant medications.
Timepoint [3] 289244 0
Monitored and recorded until 21 days post first dose.
Secondary outcome [1] 302093 0
Pharmacokinetic profiles (Cmax, Tmax, T1/2, AUCt, AUCinf and clearance) of FT011 in serum and urine after single and multiple doses.
Timepoint [1] 302093 0
Single dose (Part A and Part B): At 15 and 30 mins and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose

Multidose (Part C): At 15 and 30 mins and 1, 2, 3, 4, 6, 8, 12 and 24 hours post dose 1, pre dose 2 and 7, and 24 hours post dose 14
Secondary outcome [2] 302095 0
Part C only: urinary ACR and eGFR measured by CKD-EPI equation in patients with diabetic nephropathy
Timepoint [2] 302095 0
At Day 1, Days 7 - 14 inclusive, and Day 21

Eligibility
Key inclusion criteria
Healthy volunteers (Part A, Part B, Part C):
- Male aged 18 to 45 years old inclusive
- Good general health without clinically significant medical history
- Body mass index < 30

Patients (Part C):
- males aged 18 to 70 years old inclusive
- have Diabetes Mellitus Type 2
- have overt albuminuria
- have eGFR >/= 30 and < / = 60 mL/min
- currently taking either an ACEi or an ARB at a stable dose.
Minimum age
18 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Healthy volunteers (Part A, Part B, Part C):
- Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose, or an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
- Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months.
- Have had serious angioedema episodes within the previous 3 years or requiring angioedema medication in the previous two years.
- Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
- Have any clinically significant abnormality at Screening (determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead ECG, or positive urine screen for drugs of abuse), a psychiatric condition that precludes compliance with the protocol, or any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma

Patients (Part C):
- Have a history of untreated or uncontrolled proliferative or pre-proliferative diabetic retinopathy
- Have evidence of hepatic dysfunction, HbA1c > 11.0%, serum potassium > 6 mmol/L.
- Have untreated urinary tract infection or other medical conditions that impact urinary protein values
- Have unstable angina pectoris or New York Heart Association Class III or IV congestive heart failure.
- Have a history of any major medical condition or any condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
- Have any risk of bleeding
- Use of anticoagulant drugs including warfarin or heparin, low molecular weight heparin, danaparoid, hirudin, or others.
- Have other specific renal conditions known to be the cause of renal disease, and patients with other specific, clinically significant renal disease.
- Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma.

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)
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
As this is the first time FT011 has been administered to humans, no formal samples size calculations have been performed, and statistics will be descriptive. However, the number of subjects planned for dosing is usual for this stage of development and is adequate to provide information for further development and future studies.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2013
Actual
20/05/2013
Date of last participant enrolment
Anticipated
Actual
15/05/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287017 0
Commercial sector/Industry
Name [1] 287017 0
Fibrotech Therapeutics Pty Ltd
Country [1] 287017 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Fibrotech Therapeutics Pty Ltd
Address
Level 9, 278 Collins St
Melbourne
Victoria 3000
Country
Australia
Secondary sponsor category [1] 285800 0
None
Name [1] 285800 0
Address [1] 285800 0
Country [1] 285800 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289057 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 289057 0
Ethics committee country [1] 289057 0
Australia
Date submitted for ethics approval [1] 289057 0
03/04/2013
Approval date [1] 289057 0
23/04/2013
Ethics approval number [1] 289057 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39002 0
Dr Jason Lickliter
Address 39002 0
Nucleus Network
Level 5
Burnet Building
89 Commercial Road
Melbourne
Victoria 3004
Country 39002 0
Australia
Phone 39002 0
+61 3 9076 8906
Fax 39002 0
Email 39002 0
[email protected]
Contact person for public queries
Name 39003 0
Ann Hamer
Address 39003 0
Fibrotech Therapeutics Pty Ltd
Level 9, 278 Collins St
Melbourne
Victoria 3000
Country 39003 0
Australia
Phone 39003 0
+61 3 9657 0705
Fax 39003 0
Email 39003 0
[email protected]
Contact person for scientific queries
Name 39004 0
Ann Hamer
Address 39004 0
Fibrotech Therapeutics Pty Ltd
Level 9, 278 Collins St
Melbourne
Victoria 3000
Country 39004 0
Australia
Phone 39004 0
+61 3 9657 0705
Fax 39004 0
Email 39004 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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