Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2019-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of RO7017773 (Part 1)
timeFrame: Day 1 to Day 5
measure: Cmax of RO7017773 (Part 2)
timeFrame: Day 1 to Day 5
measure: Taste Assessment, as Measured by Taste Questionnaire (Part 2)
timeFrame: Day 1
Secondary outcomes:
measure: Taste Assessment, as Measured by Taste Questionnaire (Part 1)
timeFrame: Day 1
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline through end of study (approximately 6 weeks)
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: