Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001228572
Ethics application status
Approved
Date submitted
5/11/2015
Date registered
10/11/2015
Date last updated
20/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of CRD-102 in a Fasted and Fed state in Healthy Adult Volunteers
Scientific title
Evaluating the Safety, Pharmacokinetics and Haemodynamic Effect of CRD-102 in a Fasted and Fed state in Healthy Adult Male Volunteers
Secondary ID [1] 287811 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart failure 296687 0
Condition category
Condition code
Cardiovascular 296925 296925 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The investigational product for this trial is CRD-102. CRD-102 is currently available as an immediate release tablet, but the Extended Release version is currently for investigational/trial use only.

14mg of CRD-102 will be administered to participants via the oral route. CRD-102 comes in 2mg minitablets. To make up a dose of 14mg, 7 minitablets will be encapsulated by the pharmacist into a capsule, and this will be administered to the volunteers orally. Administration of this tablet is done in a supervised clinical unit, hence compliance will not be an issue. Safety bloods, ECGs, vital signs are monitored regularly to ensure participants safety.

This trial is a food effect trial. Participants will be administered 14mg CRD-102 in a fasted state, where participants are required to fast from food for a minimum of 8 hours prior to dosing. Water is permitted.

Following dosing of CRD-102 in the fasted state, a washout period of 7 days is required, prior to the second dose. Participants will be readmitted to the clinical unit, and will be administered the capsule of 14mg CRD-102 following breakfast which will be provided.

The investigational product will be stored in a locked pharmacy with secure authorised personnel access, and all drug accountability logs will need to be completed.
Intervention code [1] 293203 0
Treatment: Drugs
Comparator / control treatment
Administration of CRD-102 in the fasting state is the comparator/control in this trial
Control group
Active

Outcomes
Primary outcome [1] 296532 0
Evaluating the Safety of CRD-102 in a Fasted and Fed state in Healthy Adult Volunteer
Timepoint [1] 296532 0
Safety bloods will be done pre-dose and 24 hours post dose
Participants will be dosed in a monitored/supervised condition
Physical examinations will be performed pre-dose, 24 hours post dose and at the end of study. (5 days post last dose)
Blood pressures will be checked 4, 8 12, 24 hours post dose.
ECGs will be performed 2, 4, 8 12, 24 hours post dose.
Primary outcome [2] 296539 0
Evaluating the Pharmacokinetics of CRD-102 in a Fasted and Fed state in Healthy Adult Volunteers
Timepoint [2] 296539 0
blood samples will be taken at 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours post dose
Primary outcome [3] 296540 0
Evaluating the Haemodynamic Effect of CRD-102 in a Fasted and Fed state in Healthy Adult Volunteers
Timepoint [3] 296540 0
Blood pressures will be checked 4, 8 12, 24 hours post dose.
ECGs will be performed 2, 4, 8 12, 24 hours post dose.
Secondary outcome [1] 318695 0
To assess tolerability of CRD-102 in fasted and fed state This will be done via adverse event monitoring that will occur from dosing until end of study. Possible adverse reactions would include nausea/headaches/dizziness/or drop in blood pressures. Subjects will be assessed in person by nurses/clinical unit and medical staff on a regular basis to ensure wellbeing. This will occur at various timepoints throughout the study, ie 2, 4 8, 12 and 24 hours post dose when ECGs, blood pressures are done. Should there be any concerns expressed by the subjects, subjects will be assessed by a medical doctor to determine if further treatments or investigations are required.
Timepoint [1] 318695 0
From 0 hours (time of administration) until 24 hours post dose for each fasted/fed group, and at end of study, 5 days post fed group

Eligibility
Key inclusion criteria
1. Provide written informed consent prior to any study procedure and agree to adhere to all protocol requirements
2. Be male aged 18 to 45 years old at the time of consent and willing to use an acceptable method of contraception for the duration of the study
3. Be in good general health without clinically significant medical history
4. Have a body mass index (BMI) between 19- 30 kg/m2 inclusive
5. Have a documented 12-lead ECG with no clinically significant abnormalities, as determined by the Investigator.
6. Have no clinically significant abnormalities in screening or Day -1 laboratory tests, as determined by the Investigator
7. Have negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test results
8. Have no dietary restrictions, and be willing to consume standard meals provided
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Receipt of any investigational agent or drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational product
2. Use of prescription drugs within 4 weeks prior to first dosing.
3. Use of over the counter medications in the 2 weeks (4 weeks for St. John’s Wort) prior to dosing, with the exception of paracetamol or topical over the counter medications with no evidence of systemic absorption.
4. Clinically relevant findings in the medical history, laboratory examination and physical examination, especially with regards to cardiovascular system and renal function
5. A positive urine test for drugs of abuse or alcohol at Screening or on the day of admittance to the Study Unit
6. Any major surgical procedure within one month of entry into the study
7. Have difficulties communicating reliably with the Investigator or unlikely to co-operate with the requirements of the study.
8. Any other condition which in the view of the Investigator is likely to interfere with study or put the subject at risk.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Food effect study. All participants will be administered investigational product in a fasted and fed state. The fasted and fed cohort will be separated by 1 week.
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
This is a PK study, hence no statistical caluclations was required to calculate the power of this study. Sample size of n=8 per group was nominated to provide sufficient PK data for detailed pharmacokinetic analysis including Cmax, tmax, AUC, t 1/2 , Vd and Clearance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2015
Actual
23/11/2015
Date of last participant enrolment
Anticipated
6/12/2015
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
8
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4583 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 12184 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 292336 0
Commercial sector/Industry
Name [1] 292336 0
Cardiora Pty Ltd
Country [1] 292336 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cardiora Pty Ltd
Address
Level 9, 278 Collins Street, Melbourne 3000 Vic
Country
Australia
Secondary sponsor category [1] 291016 0
None
Name [1] 291016 0
Address [1] 291016 0
Country [1] 291016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293802 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 293802 0
55 Commercial Rd, Melbourne 3004 VIC
Ethics committee country [1] 293802 0
Australia
Date submitted for ethics approval [1] 293802 0
30/09/2015
Approval date [1] 293802 0
05/11/2015
Ethics approval number [1] 293802 0

Summary
Brief summary
This trial is conducted to evaluate the Safety, Pharmacokinetics and Haemodynamic Effect of CRD-102 in a Fasted and Fed state in Healthy Adult Volunteers. 8 Healthy Adult volunteers will be administered a single dose of CRD-102 in a fasted state, followed by a single dose of CRD-102 in a fed state 7 days later.
PK samples, blood pressures, ECGs will be taken to assess the PK and haemodynamic profile of the medication following administration in a fasted and fed state.

Healthy volunteers will be screened up to 28 days prior to trial enrolment, Following enrolment, 8 healthy volunteers will be dosed with CRD-102 in a fasting state on day 1, followed by administration of CRD-102 in a fed state following a 7 day wash out. Subjects will return to clinic for a follow up 5 days after administration of the last dose of investigational product for a safety visit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61374 0
Dr Jason Lickliter
Address 61374 0
Nucleus Network
Level 5, 89 Commercial Rd, Melbourne 3000, VIC.
Country 61374 0
Australia
Phone 61374 0
+61390768900
Fax 61374 0
Email 61374 0
[email protected]
Contact person for public queries
Name 61375 0
Bob Soh
Address 61375 0
Cardiota Pty Ltd
Level 9, 278 Collins street, Melbourne 3000, VIC
Country 61375 0
Australia
Phone 61375 0
+61396570700
Fax 61375 0
Email 61375 0
[email protected]
Contact person for scientific queries
Name 61376 0
Bob Soh
Address 61376 0
Cardiora Pty Ltd
Level 9, 278 Collins street, Melbourne 3000, VIC
Country 61376 0
Australia
Phone 61376 0
+61396570700
Fax 61376 0
Email 61376 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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