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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984229
• Other study ID #: NP28990
• Status: Completed
• Phase: Phase 1
• First received: November 7, 2013
• Last updated: July 1, 2016
• Start date: December 2013
• Est. completion date: February 2014

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Posaconozole
400 mg Posaconozole adminstered orally twice daily.
• RO5424802
Single oral dose of RO5424802

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Area under the concentration-time curve (AUC)		Up to 24 days	No
Primary	Efficacy: Maximum plasma concentration (Cmax)		Up to 24 days	No
Secondary	Safety: Incidence of adverse events		24 days	No
Secondary	Efficacy: AUC of metabolite		Up to 24 days	No
Secondary	Efficacy: Cmax of metabolite		Up to 24 days	No