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 |
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.
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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