None listed
Conditions
Brief summary
This will be a single-blind, randomized, single-dose, triple-cross over (a Latin square design), single-centre study. 24 Subjects will be enrolled. Each subject will receive all three treatments in random order. At each administration day approximately 1/3 of subjects will receive treatment A, 1/3 treatment B, and 1/3 treatment C and this will switch around on the second administration day and then again on third administration day until all participants have been administered all three treatments. Screening: Subjects will be screened for the study. Eligible subjects will return for the admission to the Unit within four (4) weeks following screening. All subjects will be instructed to maintain their lifestyle and background medications, if any. Baseline: Subjects will be admitted to the Unit in the evening of Day -1. Blood draw to establish the baseline for all measured endpoints will be drawn in the morning of Day 0. Randomisation: Following the completion of all baseline assessments and draws on Day 0, eligible subjects will be randomized so that approximately 1/3 of subjects will receive treatment A, 1/3 treatment B, and 1/3 treatment C. The first dose of study medication will be then promptly administered. Drug administration and assessment periods: Each subject will receive a drug three times in random pre-determined order, single dose, separated by at least 14 days of washout. Following each administration, blood for PK and safety will be drawn and safety and tolerability assessments will be conducted over the ensuing 36 hours. Final tolerability/safety assessment: Approximately seven (7) days following the administration of the last medication, the site will follow up over the phone with the subjects regarding any tolerability or safety issue; if clinically necessary, they could be invited back to the Unit for follow up tests or evaluation.
Interventions
The treatments are HTD1801, 1500mg, BBR 1000mg and UDCA 1000mg, one oral dose of each treatment. There will be a washout period of at least 7 days and up to 10 days..
Participants will be admitted to the treatment unit where the investigational products will be administered.
Sponsors
Clinical Network Services (CNS) Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Males and females 18-45 years of age BMI 20-35 kg/m2 No history of CV or any other major disease No pathologies in blood haematology or chemistry
Exclusion criteria
BP greater than or equal to 160/95 HR greater than or equal to 100bpm or less than or equal to 45 bpm Significant cardiac arrhythmia Untreated hypo- or hyperthyroidism Clinically significant liver (greater than 3 times ULN) and/or kidney impairment Inability to tolerate UDCA or BBR Contraindications to BBR and UDCA G6PD deficiency Gastritis or gastric ulcers Pregnancy Any background medication or dietary supplements which might alter with pharmacokinetic profile of IMP or active controls Any other clinically meaningful condition, in the opinion of the investigator, which would make participation potentially unsafe
Outcome results
None listed