A Phase 1b, Single-centre, Open-label Study to Evaluate Food Effect and the Drug-Drug Interaction of Omeprazole, Itraconazole and Rifampin on Tinlarebant in Healthy Adult Subjects
RBP4 Pty Ltd
48 participants
Jan 7, 2024
Interventional
Conditions
Summary
This is an open-label study to evaluate the effect of food and drug-drug interaction with tinlarebant. This study will assess the effect of omeprazole, itraconazole,rifampin and food on the pharmacokinetics of tinlarebant.
Eligibility
Inclusion Criteria1
- Healthy male or female, aged between 18 to 65 years of age, inclusive, at screening.
Exclusion Criteria1
- History of any clinically significant disorder, including cardiovascular (including unstable angina, myocardial infarction, chronic heart failure), haematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic (including seizures, strokes, brain tumours), and psychiatric diseases, or any disorder that the PI (or delegate) considers may prevent the successful completion of the study or influence the absorption, distribution, metabolism, excretion, or action of the study drug.
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Interventions
This study will be conducted in four independent Parts as follow: Part 1(Tinlarebant+Omeprazole): 12 participants will take tinlarebant (5 mg) on Day 1 and Day 22, and take Omeprazole(40 mg) once daily on each Day 18-26. Part 2 (Tinlarebant+Itraconazole): 12 participants will take tinlarebant (5 mg) on Day 1 and Day 22, and take Itraconazole (200 mg) twice daily on each Day 17-26. Part 3 (Tinlarebant+Rifampin): 12 participants will take tinlarebant (5 mg) on Day 1 and Day 22, and take Rifampin (600 mg) once daily on each Day 14-26. Part 4 (Food Effect): 12 participants will be randomized into two treatment sequences: Sequence 1: to take tinlarebant (5mg) on Day 1 under fasted condition, and Day 22 under fed condition. Sequence 2: to take tinlarebant (5mg) on Day 1 under fed condition, and Day 22 under fasted condition. - Fasted condition: minimum 10 hour fast, water allowed until 1 hour before study drug administration. - Fed condition: participants will have a standard high fat, high calorie meal includes: 2 eggs fried in butter, 2 rashers of bacon, 2 slices of toast with 16 g butter per slice, 125 g of hash browns and 240 mL of full cream milk. All the study drug all be administrated orally, and recorded in dosing diaries at home or Electronic Medical Record on site.
Locations(1)
View Full Details on ANZCTR
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ACTRN12624000031561