A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
This open-label study will investigate whether multiple oral doses of posaconazole affect the single dose pharmacokinetics of alectinib in healthy volunteers.
Key facts
- Study ID
- NCT01984229
- Run by
- Hoffmann-La Roche
- People needed
- 23
- Starts
- 2013-12-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2016-10-11
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Body mass index (BMI) between 18 to 32 kilogram per square meter (kg/m\^2)
- 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 and follow-up
You may not qualify if…
- 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, human immunodeficiency virus (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. Participants 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
Where it is running
- Study site — Austin, Texas, United States
Full record on ClinicalTrials.gov
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