A 2 Part, Randomized, Open-Label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Phase II Tablet Formulation Compared to the Current Phase I Capsule Formulation and the Effect of Food and Taste Assessment on the Phase II Tablet Formulation in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax of RO7017773 (Part 2)
Study Overview
Brief Summary
This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the taste of the tablet formulation is perceived with and without added sweetener/flavoring.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 1
Participants will receive 4 single oral doses of RO7017773 under either fed or fasted conditions, one of which will be a taste assessment. There will be a 7-10 day washout period between doses.
Intervention: RO7017773 Phase I Capsule (Drug)
Part 1
Participants will receive 4 single oral doses of RO7017773 under either fed or fasted conditions, one of which will be a taste assessment. There will be a 7-10 day washout period between doses.
Intervention: RO7017773 Phase II Tablet Unflavored (Drug)
Part 2
Participants will receive 2 single oral doses of RO7017773, either sweetened/flavored, or unflavored and dispersed in juice. There will be a 7-10 day washout period between doses.
Intervention: RO7017773 Phase II Tablet Unflavored (Drug)
Part 2
Participants will receive 2 single oral doses of RO7017773, either sweetened/flavored, or unflavored and dispersed in juice. There will be a 7-10 day washout period between doses.
Intervention: RO7017773 Phase II Tablet Sweetened/Flavored (Drug)
Outcomes
Primary Outcomes
Cmax of RO7017773 (Part 2)
Time Frame: Day 1 to Day 5
Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
Time Frame: Day 1 to Day 5
Taste Assessment, as Measured by Taste Questionnaire (Part 2)
Time Frame: Day 1
Taste was assessed using a questionnaire that asking participants to rate the overall taste of study drug dispersed in various vehicles on a scale from 1-5, with 1=no taste, and 5=very intense taste.
Secondary Outcomes
- Taste Assessment, as Measured by Taste Questionnaire (Part 1)(Day 1)
- Percentage of Participants With Adverse Events (AEs)(Baseline through end of study (approximately 6 weeks))