A Study of the Effects of Posaconazole on RO5424802 Pharmacokinetics in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:6/3/2016
Start Date:December 2013
End Date:February 2014

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An Open-Label, Three-Period, Fixed Sequence Study to Investigate the Effect of Multiple Oral Doses of Posaconazole, a Potent Cytochrome P450 3A Inhibitor, on the Single Dose Pharmacokinetics of RO5424802 in Healthy Subjects

This open-label study will investigate whether multiple oral doses of Posaconazole affect
the single dose pharmacokinetics of RO5424802 in healthy volunteers.


Inclusion Criteria:

- Healthy adults, 18 to 55 years of age.

- Body mass index (BMI) between 18 to 32 kg/m2.

- Male volunteers must use effective contraception as outlined in the protocol.

- Willingness to abstain from alcohol and xanthine-containing beverages or food
(coffee, tea, cola, chocolate and "energy drinks") from 72 hours prior to the first
dose until discharged.

- Willingness to avoid prolonged sun exposure and guard against sunburn during study &
follow-up.

Exclusion Criteria:

- Clinically significant medical history or findings in physical examination, vital
signs, or laboratory test results prior to study start.

- Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse, or
tobacco.

- Women of childbearing potential, or males with pregnant or lactating partners.

- Regular smoking within 6 months prior to first dosing. Subjects should avoid smoky
environments for at least 1 week prior to each cotinine screen.

- Excessive alcohol consumption.

- Use of any metabolic inducers (including herbals such as St. John's Wort) within 4
weeks or 5 half-lives (whichever is longer) before the first dose of study
medication, including but not limited to: rifampin, rifabutin, glucocorticoids,
carbamazepine, phenytoin and phenobarbital.

- Strenuous activity, sunbathing, or contact sports are not allowed from 4 days prior
to entry into the clinical site until study follow-up.

- Participation in an investigational drug or device study within 45 days (or 6 months
for biologic therapies) prior to first dosing.
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