Trial Details

Recruiting
Basic Information
Clinical ID c2293
Identifier ISRCTN14438276
Trial Title A two-part, open-label, randomised, cross-over study to compare new tablet formulations of RO7486967 to the capsule formulation, to perform a preliminary dose proportionality assessment and to estimate the effect of food on the pharmacokinetics of the tablet formulations in healthy participants
Trial URL Visit Original Page
Study Information
Study Results

Yes
Conditions Inflammatory bowel disease (IBD), respiratory diseases including chronic obstructive pulmonary disease (COPD) and severe asthma, and Parkinson disease Not Applicable
Interventions 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.
Participant Information
Sponsor F. Hoffmann-La Roche Ltd
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2022-09-21