A study in healthy volunteers to compare the test medicine as both a tablet and capsule, to determine the correlation between increases in doses of the test medicine and the amount of test medicine taken up by the body, and to estimate how food affects the test medicine when given as a tablet

Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Part 1: Participants will be randomised to receive a single dose of each of reference Hard Capsules RO7486967 200 mg (2 x 100 mg) in the fasted state, RO7486967 Immediate Release Tablet, 200 mg in the fasted state, and RO7486967 Immediate Release Tablet, 200 mg in the fed state, across three periods. Either option Part 2a or 2b will be chosen based on the results of Part 1. Part 2a: Participants will be randomised to receive a single dose of each of RO7486967 Immediate Release Tablet, 200 mg in the fasted state, RO7486967 Immediate Release Tablet, 25 mg in the fasted state and RO7486967 Immediate Release Tablet, 25 mg in the fed state, across three periods. Part 2b: Participants will be randomised to receive a single dose of each reference Hard Capsules RO7486967 200 mg (2 x 100 mg) in the fasted state, RO7486967 Modified Release Tablet, 200 mg in the fasted state, and RO7486967 Modified Release Tablet, 200 mg in the fed state and RO7486967 Modified Release Tablet, 25 mg in the fasted state, across four periods. CONDITION: Inflammatory bowel disease (IBD), respiratory diseases including chronic obstructive pulmonary disease (COPD) and severe asthma, and Parkinson’s disease ; Not Applicable PRIMARY OUTCOME: ; Parts 1 and 2:; 1. Pharmacokinetic (PK) parameters, including (but not limited to) Tmax, Cmax, AUC(0‐last), AUC(0‐inf), lambda‐z and T1/2 for RO7486967 in plasma, as applicable, measured using blood samples at pre‐dose and at multiple time points, up to 16 hours post‐dose on Day 1, and thereafter on Days 2 and 3.; 2. Assessment of food effect on plasma PK parameters Cmax, AUC(0‐last) and AUC(0‐inf) for RO7486967 and RO7428130, as applicable, in the fed state (test regimens) compared to the fasted state (reference regimens), for RO7486967 in plasma measured using blood samples at pre‐dose and at multiple time points, up to 16 hours post‐dose on Day 1, and thereafter on Days 2 and 3.; ; Part 1 and Part 2b only:; 1. Relative bioavailability of plasma PK parameters Cmax, AUC(0‐last) and AUC(0‐inf) for RO7486967 and RO7428130, as applicable, for tablet formulations (test regimens) compared to a capsule formulation (reference regimen), in plasma measured using blood samples at pre‐dose and at multiple time points, up to 16 hours post‐dose on Day 1, and thereafter on Days 2 and 3.; ; Part 2 only:; 1. Dose proportionality of plasma PK parameters Cmax, AUC(0‐last) and AUC(0‐inf) for RO7486967 and RO7428130, as applicable, in the chosen 25 mg RO7486967 tablet formulation (test regimen) compared to the chosen 200 mg RO7486967 tablet formulation (reference regimen), in plasma measured using blood samples at pre‐dose and at multiple time points, up to 16 hours post‐dose on Day 1, and thereafter on Days 2 and 3.; SECONDARY OUTCOME: ; Parts 1 and 2:; 1. Additional safety and tolerability information for RO7486967 collected by assessing the incidence of adverse events (AEs), and change from baseline for Columbia‐Suicide Severity Rating Scale (C‐SSRS), vital signs, electrocardiograms (ECGs), and laboratory safety tests, from the time of signing the informed consent form to up to 21 days post‐final dose (approximately 11 weeks); INCLUSION CRITERIA: 1. Healthy males or non‐pregnant, non‐lactating healthy females 2. Aged 18 to 55 years inclusive at the time of signing the informed consent 3. Body mass index (BMI) of 18.0 to 30.0 kg/m², inclusive, as measured at screening 4. Participants must be willing and able to communicate and participate in the whole study and comply with study requirements 5. Participants must provide written informed consent 6. Participants must agree to adhere to the contraception requirements defined in the clinical protocol
Epistemonikos ID: fce49b9b58da5632e964a486ba0a2321093b2746
First added on: May 25, 2022