NCT03847987

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.
DRUG	RO7017773 Phase II Tablet Sweetened/Flavored	Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.

Timeline

• Start date: 2019-03-12
• Primary completion: 2019-04-22
• Completion: 2019-04-22
• First posted: 2019-02-20
• Last updated: 2020-05-28
• Results posted: 2020-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study