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

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: RO7017773 Phase I Capsule; Drug: RO7017773 Phase II Tablet Unflavored; Drug: RO7017773 Phase II Tablet Sweetened/Flavored

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Non-smoker for at least six months
• Healthy, as judged by the Investigator
• Women of non-childbearing potential (WONCBP) who are not pregnant or lactating
• Men must be willing to remain abstinent or agree to use contraceptive measures with partners who are women of childbearing potential (WOCBP), and must refrain from donating sperm, for at least 28 days after the last dose of study drug

Exclusion Criteria

• History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
• History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g. meningitis)
• A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities
• Have used or intend to use over-the-counter or prescription medication including herbal medications within 30 days prior to dosing
• Participation in an investigational drug or device study within 90 days prior to screening
• Human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: RO7017773 Phase I Capsule; Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.; Drug: RO7017773 Phase II Tablet Unflavored; Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.
EXPERIMENTAL: 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.	Drug: RO7017773 Phase II Tablet Unflavored; Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.; Drug: RO7017773 Phase II Tablet Sweetened/Flavored; Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)		Day 1 to Day 5
Cmax of RO7017773 (Part 2)		Day 1 to Day 5
Taste Assessment, as Measured by Taste Questionnaire (Part 2)	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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Taste Assessment, as Measured by Taste Questionnaire (Part 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.	Day 1
Percentage of Participants With Adverse Events (AEs)		Baseline through end of study (approximately 6 weeks)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 12, 2019
• Primary Completion (ACTUAL): April 22, 2019
• Study Completion (ACTUAL): April 22, 2019

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (ACTUAL): February 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 28, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BP40950

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No