None listed
Conditions
Brief summary
This study will compare how much SOR102 is found in the blood and stool and look at the safety of both a tablet and capsule dose formulation of SOR102. The capsule formulation has been tested in healthy volunteers before, with the tablet formulation being given for the first time in humans in this study. SOR102 is being developed as a potential treatment for inflammatory bowel disease. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 65 years old.
Interventions
Approximately 16 healthy men or women will be enrolled in this study. There will be three periods in the study study.
- Period 1: In Period 1, participants will receive the SOR102 capsule formulation at a dose of 675mg given orally twice a day under fasted conditions for 7 days, Participants will receive their morning and evening dose of SOR102 following a fast of at least 2 hours and will be required to continue to fast from food for a minimum of 1 hour following administration of SOR102 . Wit
Approximately 16 healthy men or women will be enrolled in this study. There will be three periods in the study study. - Period 1: In Period 1, participants will receive the SOR102 capsule formulation at a dose of 675mg given orally twice a day under fasted conditions for 7 days, Participants will receive their morning and evening dose of SOR102 following a fast of at least 2 hours and will be required to continue to fast from food for a minimum of 1 hour following administration of SOR102 . With the exception of the 240 mL of water taken with the dose, participants will not be allowed fluids from 2 hours prior to until 1 hour after dosing. Following completion of 7 days of SOR102 dosing, participants will be discharged from the Clinical Research Unit on Day 8 for the first 7 day washout period. - Period 2: Following the washout period, participants will return to the Clinical Research Unit for Period 2 where they will receive the SOR102 tablet formulation at a dose of 600mg given orally twice a day under fasted conditions for 7 days. Participants will receive their morning and evening dose of SOR102 following a fast of at least 2 hours and will be required to continue to fast from food for a minimum of 1 hour following administration of SOR102 . With the exception of the 240 mL of water taken with the dose, participants will not be allowed fluids from 2 hours prior to until 1 hour after dosing. Following completion of 7 days of SOR102 dosing, participants will be discharged from the Clinical Research Unit on Day 8 for the second 7 day washout period. - Period 3: Following the washout period, participants will return to the Clinical Research Unit for Period 3 where they will receive the SOR102 tablet formulation at a dose of 600mg given orally twice a day under nonfasted conditions for 7 days. Each dose of SOR102 will be taken 15 minutes after completion of a standard non-high fat meal. The meal will have about 45 to 65 grams of carbohydrates, 25 to 40 grams of protein, and 10 to 15 grams of fat. Following completion of 7 days of SOR102 dosing, participants will be discharged from the Clinical Research Unit on Day 8. Participants will return to the Clinical Research Unit for an ambulatory follow-up visit 1 week later.
Sponsors
Sorriso Pharmaceuticals Australia, Pty. Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Body weight at least 50kg and no more than 110kg and body mass index within the range 18-35 kg/m2 (inclusive) Deemed healthy as determined by medical history, physical examination, vital sign measurements, ECG, and laboratory safety tests No clinically relevant abnormalities in clinical laboratory evaluations Normal bowel habits Not lactating or pregnant 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
Clinically relevant history of physical or mental health abnormalities that might interfere with the study Clinically relevant abnormal laboratory results, 12-lead ECG and vital signs, or physical findings History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the study drug. History of latent or active tuberculosis. Positive (or 2 indeterminate) QuantiFERON test results. Positive test for hepatitis B surface antigen, anti-hepatitis C antibody or human immunodeficiency virus I and II. Positive urine test for drugs of abuse or alcohol breath test Taken part in a clinical study and has received a medication or a new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to dosing of current study medication. Use or intended use of any prohibited medications Known history of heart disease. History of significant GI disease, including GI motility disorders. History of abnormal bowel habits (e.g., a history of chronic constipation or chronic diarrhea). Previous surgery to the GI tract with the exception of appendectomy and hernia repair Systolic BP (SBP) of 160 mmHg or diastolic BP (DBP) of 95 mmHg Orthostatic intolerance at Screening Participant is unlikely to co-operate with the requirements of the study, in the opinion of the Investigator.
Outcome results
None listed