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
Status: | Active, not recruiting |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 4/6/2019 |
Start Date: | March 12, 2019 |
End Date: | April 11, 2019 |
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
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.
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.
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
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