A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: RO7017773 Phase I Capsule; Drug: RO7017773 Phase II Tablet Unflavored; Drug: RO7017773 Phase II Tablet Sweetened/Flavored

• Registration Number: NCT03847987
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-20
• Study Start: 2019-03-12
• Primary Completion: 2019-04-22
• Study Completion: 2019-04-22
• Results First Submitted: 2020-04-08
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-14
• Last Update Submitted: 2020-05-14
• Results First Posted: 2020-05-28
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1	RO7017773 Phase II Tablet Unflavored	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.
Part 2	RO7017773 Phase II Tablet Unflavored	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.
Part 2	RO7017773 Phase II Tablet Sweetened/Flavored	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.
Part 1	RO7017773 Phase I Capsule	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.

Primary Outcome Measures

Name	Time	Method
Cmax of RO7017773 (Part 2)	Day 1 to Day 5
Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)	Day 1 to Day 5
Taste Assessment, as Measured by Taste Questionnaire (Part 2)	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 Outcome Measures

Name	Time	Method
Taste Assessment, as Measured by Taste Questionnaire (Part 1)	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.
Percentage of Participants With Adverse Events (AEs)	Baseline through end of study (approximately 6 weeks)

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Salt Lake City, Utah, United States