Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO7017773 Phase I Capsule

Drug

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

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.

RO7017773 Phase II Tablet Sweetened/Flavored

Drug

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

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)

    Time frame: Day 1 to Day 5

  2. Cmax of RO7017773 (Part 2)

    Time frame: Day 1 to Day 5

  3. Taste Assessment, as Measured by Taste Questionnaire (Part 2)

    Time frame: Day 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.

Secondary outcomes

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

    Time frame: Day 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.

  2. Percentage of Participants With Adverse Events (AEs)

    Time frame: Baseline through end of study (approximately 6 weeks)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2019
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.