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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04705077




Registration number
NCT04705077
Ethics application status
Date submitted
8/01/2021
Date registered
12/01/2021
Date last updated
25/03/2021

Titles & IDs
Public title
A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
Scientific title
A Phase 1, Open-Label Study to Assess the Single Dose Pharmacokinetics of Suspension and Capsule Formulations of SR419 and Repeat Dose Pharmacokinetics of Capsule Formulation of SR419, and to Assess the Effect of a High-Fat Meal on the Pharmacokinetics of SR419 in Healthy Subjects
Secondary ID [1] 0 0
SR419-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR419

Experimental: Single Dose Treatment - Each subject will be assigned to the fixed period sequence.

* Period 1: SR419 suspension in the fasted state;
* Period 2: SR419 capsule in the fasted state;
* Period 3: SR419 capsule in the fed state (high-fat meal).

Experimental: Repeated Dose Treatment - Each subject will receive 30 mg of SR419 capsule, once every 8 hours (Q8h), for 5 days.


Treatment: Drugs: SR419
2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Peak plasma concentration of SR419
Timepoint [1] 0 0
Up to Day 12
Primary outcome [2] 0 0
Time of peak plasma concentration of SR419
Timepoint [2] 0 0
Up to Day 12
Primary outcome [3] 0 0
Area under the plasma concentration-time curve of SR419
Timepoint [3] 0 0
Up to Day 12
Primary outcome [4] 0 0
Apparent total clearance of SR419
Timepoint [4] 0 0
Up to Day 12
Primary outcome [5] 0 0
Terminal half-life of SR419
Timepoint [5] 0 0
Up to Day 12
Primary outcome [6] 0 0
Accumulation ratio of SR419
Timepoint [6] 0 0
Up to Day 12
Secondary outcome [1] 0 0
Peak plasma concentration of SR419 metabolites
Timepoint [1] 0 0
Up to Day 12
Secondary outcome [2] 0 0
Time of peak plasma concentration of SR419 metabolites
Timepoint [2] 0 0
Up to Day 12
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve of SR419 metabolites
Timepoint [3] 0 0
Up to Day 12
Secondary outcome [4] 0 0
Terminal half-life of SR419 metabolites
Timepoint [4] 0 0
Up to Day 12
Secondary outcome [5] 0 0
Accumulation ratio of SR419 metabolites
Timepoint [5] 0 0
Up to Day 12
Secondary outcome [6] 0 0
Number of participants with adverse events
Timepoint [6] 0 0
Up to Day 15

Eligibility
Key inclusion criteria
1. Healthy males or females who are 18 to 64 years of age inclusive, are eligible.
2. Body weight > 50 kg (110 pounds) and body mass index (BMI) between 18 and 30 kg/m2.
3. Male or female subjects must agree to use contraception methods.
4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Clinically significant history of central nervous system (CNS) disease.
2. Current or chronic history of liver disease or known hepatic or biliary abnormalities
3. History of regular alcohol consumption within 6 months of screening defined as: an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~285 mL) of beer, 1 glass (125 mL) of wine or 1 measure (25 mL) of spirits.
4. History of significant drug abuse within one year of screening or use of soft drugs (such as marijuana) within 3 months prior to screening or hard drugs (such as cocaine, methamphetamine, crack) within 1 year prior to screening.
5. History of sensitivity to any of the components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates participation.
6. History of asthma (excluding resolved childhood asthma), anaphylaxis or anaphylactoid reactions, severe allergic responses.
7. History of hypercoagulable state or history of thrombosis.
8. A positive Hepatitis B surface antigen, Hepatitis C antibody or human immunodeficiency virus (HIV) antibody result.
9. A positive urinary cotinine test or history of regular use of tobacco- or nicotine-containing products (more than 4 products per month within 6 months prior to screening) or unwilling to refrain from use of such products from Screening until completion of the final study visit.
10. A positive drug/alcohol result.
11. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
12. Unable to refrain from consumption of Seville oranges, grapefruit or grapefruit juice within 7 days prior to the first dose of IMP until the Safety Follow-up visit.
13. A positive pregnancy test result.
14. Breast-feeding and/or lactating subject.
15. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/03/2021
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SIMR (Australia) Biotech Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This will be an open-label, single-site, Phase I study to evaluate the PK, safety, and tolerability of SR419 in healthy volunteers.
Trial website
https://clinicaltrials.gov/study/NCT04705077
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Polasek
Address 0 0
CMAX Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04705077