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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: RO7017773 Phase I Capsule; Drug: RO7017773 Phase II Tablet Sweetened/Flavored; Drug: RO7017773 Phase II Tablet Unflavored

Study type: Interventional

Funder types: Industry

Identifiers

NCT03847987

BP40950

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Part 1

Experimental group

Description:

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.

Treatment:

Drug: RO7017773 Phase II Tablet Unflavored

Drug: RO7017773 Phase I Capsule

Part 2

Experimental group

Description:

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.

Treatment:

Drug: RO7017773 Phase II Tablet Sweetened/Flavored

Drug: RO7017773 Phase II Tablet Unflavored