None listed
Conditions
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.
Interventions
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
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.
Sponsors
Cardiora Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
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.
Outcome results
None listed