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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847987
• Other study ID #: BP40950
• Status: Completed
• Phase: Phase 1
• Start date: March 12, 2019
• Est. completion date: April 22, 2019

Study information

• Verified date: May 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 22, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• RO7017773 Phase I Capsule
Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.
• 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.
• RO7017773 Phase II Tablet Sweetened/Flavored
Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)		Day 1 to Day 5
Primary	Cmax of RO7017773 (Part 2)		Day 1 to Day 5
Primary	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	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
Secondary	Percentage of Participants With Adverse Events (AEs)		Baseline through end of study (approximately 6 weeks)