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

NCT03847987 | Completed Phase 1 Results FDA Drug

• 1 other identifier: BP40950
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Taste Assessment, as Measured by Taste Questionnaire (Part 1)

  Day 1

• Percentage of Participants With Adverse Events (AEs)

  Baseline through end of study (approximately 6 weeks)

Study Arms (2)

Part 1

EXPERIMENTAL

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; Drug: RO7017773 Phase II Tablet Unflavored

Part 2

EXPERIMENTAL

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; Drug: RO7017773 Phase II Tablet Sweetened/Flavored

Interventions

RO7017773 Phase I Capsule DRUG

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

Part 1

RO7017773 Phase II Tablet Unflavored 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 1; Part 2

RO7017773 Phase II Tablet Sweetened/Flavored DRUG

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

Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

Flavoring Agents

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 20, 2019
• Study Start: March 12, 2019
• Primary Completion: April 22, 2019
• Study Completion: April 22, 2019
• Last Updated: May 28, 2020
• Results First Posted: May 28, 2020

Record last verified: 2020-05

Locations

US (1)