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

NCT ID: NCT03847987

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-12
• Study Completion Date: 2019-04-22

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RO7017773 Phase I Capsule

Intervention Type: DRUG

Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.

RO7017773 Phase II Tablet Unflavored

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

RO7017773 Phase II Tablet Unflavored

Intervention Type: DRUG

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.

RO7017773 Phase II Tablet Sweetened/Flavored

Intervention Type: DRUG

Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.

Interventions

RO7017773 Phase I Capsule

Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.

Intervention Type: 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.

Intervention Type: DRUG

RO7017773 Phase II Tablet Sweetened/Flavored

Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

PRA Health Sciences

Salt Lake City, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BP40950

Identifier Type: -

Identifier Source: org_study_id