A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers

Healthy Volunteer Clinical Trial

Official title:

A Randomized, Open Label, Single Dose, Two Period, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of RO5428029 Following Oral Administration in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345942
• Other study ID #: PP25583
• Status: Completed
• Phase: Phase 1
• First received: April 29, 2011
• Last updated: November 1, 2016
• Start date: May 2011
• Est. completion date: June 2011

Study information

• Verified date: November 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, two period, crossover study will evaluate the safety and the effect of food on the pharmacokinetics of RO5428029 in healthy volunteers. In a crossover design, healthy subjects will be randomized to receive a single oral dose of RO5428029 with or without food, with a washout period of at least 7 days between dosing and a follow-up of 7 to 10 days after last dose. Anticipated time on study will be up to 21 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers, 18 to 60 years of age inclusive

• Body mass index (BMI) between 18 and 29.9 kg/m2, inclusive, and a minimum weight of 45 kg

• Female subjects must be surgically sterile or post-menopausal

• Male subjects and their partners of child-bearing potential must use 2 methods of contraception (one of which a barrier method) for the duration of the study and for at least 70 days after the last dose

Exclusion Criteria:

• Pregnant or lactating women, and male partners of women who are pregnant or lactating

• Women with reproductive potential

• History (within 3 months of screening) of alcohol consumption exceeding 2 standard units per day on average; alcohol consumption will be prohibited at least 48 hours before screening

• Positive test for drugs of abuse

• History or symptoms of any significant disease

• Positive for HIV, hepatitis B or hepatitis C infection

• Participation in an investigational drug or device study within 3 months prior to screening

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5428029
Single oral dose

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	Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration		72 hours	No
Secondary	Safety: Incidence of adverse events		approximately 3 weeks	No