None listed
Conditions
Brief summary
This is a single-centre, randomised, open-label, two-way crossover, single dose study with three treatment periods conducted in healthy participants. The study is designed to compare the PK profiles of a single oral dose of an immediate and extended release formulation of propagermanium, and to identify if there is a food-effect on the extended release formulation. Participants who meet all inclusion and none of the exclusion criteria will be evaluated throughout the study. In addition to PK assessments, safety and tolerability data will be collected during the course of the study. Approximately 14 participants will be enrolled into two cohorts (Cohort A and Cohort B). Participants in Cohort A will receive the immediate release (IR) formulation while fasting at Dose 1, the extended release (ER) formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. Participants in Cohort B will receive the ER formulation while fasting at Dose 1, the IR formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. No participant will be a member of more than one cohort. Participants will be screened from -14 days prior to dose administration. Participants will be admitted to the unit on Day -1 and will remain confined to the unit for 24 hours post-dose. On Day 1, participants will receive Dose 1 and will complete procedures as detailed in Table 3. On Days 7 and 14 participants will return to the unit and will receive Doses 2 and 3 on Days 8 and 15, respectively and will complete procedures as detailed in Table 3. Participants will return to the clinic on Day 24 for follow-up visits.
Interventions
Phase 1 study in healthy volunteers involving 2 Cohorts (Cohort A and Cohort B).
propagermanium:
Extended Release tablets of 120 mg propagermanium (4 x 30 mg tablets) for oral administration. Single dose administration over three treatment periods.
Participants in Cohort A will receive the immediate release (IR) formulation while fasting at Dose 1, the extended release (ER) formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. Participants in Cohort B will receive
Phase 1 study in healthy volunteers involving 2 Cohorts (Cohort A and Cohort B). propagermanium: Extended Release tablets of 120 mg propagermanium (4 x 30 mg tablets) for oral administration. Single dose administration over three treatment periods. Participants in Cohort A will receive the immediate release (IR) formulation while fasting at Dose 1, the extended release (ER) formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. Participants in Cohort B will receive the ER formulation while fasting at Dose 1, the IR formulation while fasting at Dose 2, and the ER formulation after a meal at Dose 3. Participants will not have a choice as to which cohort they are assigned (randomised) to and the ratio is 1:1 for each cohort. The IP will be administered with 250 mL water. All participants from both cohorts will receive study drug on Day 1 (Dose 1), Day 8 (Dose 2) and Day 15 (Dose 3), as such there will be a 7 day wash out period between treatments.
Sponsors
Clinical Network Services Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female volunteers aged between 18 to 50 years old, inclusive, with a body mass index (BMI) between 18.0 and 30.0 kg/m2, who are non-smokers or smoking less than 10 cigarettes/day. 2. Female subjects of childbearing potential must agree to practice true abstinence (when this is in line with their preferred and usual lifestyle) or to use 2 methods of highly effective contraception during the study and for 30 days after the last dose of investigational product, and must have a negative pregnancy test at screening and prior to study drug administration. 3. Male subjects and their partners must agree to use two forms of highly effective methods of contraception during the study and for 90 days after study completion, or agree to remain abstinent during the study and for 90 days after study completion. 4. Able and willing to return to the clinic for all study procedures. 5. Able and willing to provide informed consent.
Exclusion criteria
1. Pregnant and breast-feeding women. 2. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data. 3. Abnormal blood pressure as determined by the Investigator. 4. Symptomatic herpes zoster within 3 months prior to screening. 5. Known history of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), or blood testing. 6. Lymphoma, leukaemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. 7. Breast cancer within the past 10 years. 8. Alanine transaminase (ALT) >1.5x upper limit of normal (ULN). 9. Bilirubin >1.5xULN (isolated bilirubin >1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). 10. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) 11. Use of over-the-counter or prescription medication including herbal medications (with the exception of hormonal contraception for female participants) within 7 days prior to dosing or during the study period (with the exception of paracetamol). 12. Live vaccine(s) within 1 month prior to screening, or plans to receive any vaccine during the study. 13. Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to dosing. 14. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment. NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained. 15. Positive human immunodeficiency virus (HIV) antibody test. 16. Participation in any clinical study with an experimental medication or device within 30 days or 5 half-lives (whichever is longer) of enrolment. 17. Alcohol consumption greater than 28 standard drinks per week or substance abuse likely to impact protocol compliance or data quality as assessed by the Principal Investigator.
Outcome results
None listed