None listed
Conditions
Brief summary
This project is testing the safety and pharmacokinetics of a single oral dose of a new drug called GBP-088 when given with and without food. GBP-088 is being developed for the treatment of recurrent kidney stones. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. You will receive a single oral dose of active study drug on Day 1 under fasted conditions. After a 4 day washout period you will receive the same oral dose of active study drug given after eating a high fat, high calorie meal. It is hoped that this research will help determine the safety of GBP-088 when given to healthy men or women so that it can be tested in patients with recurrent kidney stone disease
Interventions
Approximately 8 healthy men or women will be enrolled in the food effect part of this study (Cohort SC-6).
In Cohort SC-6 the participants will only receive GBP-088. There will be no participants receiving placebo. Cohort SC-6 receives a single dose of GBP-088 twice. The first dose will be following an overnight fast of at least 10 hours. The second dose will be given after a 4 day washout and following a standard high fat and high calorie meal. The meal will contain about 1000 calories with
Approximately 8 healthy men or women will be enrolled in the food effect part of this study (Cohort SC-6). In Cohort SC-6 the participants will only receive GBP-088. There will be no participants receiving placebo. Cohort SC-6 receives a single dose of GBP-088 twice. The first dose will be following an overnight fast of at least 10 hours. The second dose will be given after a 4 day washout and following a standard high fat and high calorie meal. The meal will contain about 1000 calories with approximately 150 protein calories, 250 carbohydrate calories and 600 fat calories. Participants will be required to refrain from fluids for an hour before dosing and an hour after each dosing. The dose to be used in SC-6 will not be any higher than previously tested single doses and will not exceed 2000mg.
Sponsors
GondolaBio Australia 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 55 Years
Healthy volunteers
Yes
Inclusion criteria
Deemed healthy as determined by medical history, physical examination, vital sign measurements, ECG, and laboratory safety tests Not lactating or pregnant Body weight at least 50kg (male) and 45kg (female) and body mass index within the range 18-32 kg/m2 (inclusive) Capable of giving signed informed consent Agrees to be available for all study visits and cooperates fully with the requirements of the study protocol, including the schedule of assessments
Exclusion criteria
Past or current history of moderate or severe psychiatric illness Past or current history of mild, moderate, or severe substance abuse Past or current history of alcohol use disorder History of acute illness, infectious condition or chronic disease within 14 days before Screening Any history of cardiovascular, cerebrovascular, or peripheral vascular disease Use or intended use of prohibitied medications Received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) before Screening Positive alcohol breath test or urine test for drugs of abuse Positive serology panel Clinically significant vital signs Clinically significant laboratory abnormalities Clinically significant history or presence of ECG findings
Outcome results
None listed