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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01345942
First received: April 29, 2011
Last updated: August 20, 2012
Last verified: August 2012

April 29, 2011
August 20, 2012
May 2011
August 2011   (final data collection date for primary outcome measure)
Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01345942 on ClinicalTrials.gov Archive Site
Safety: Incidence of adverse events [ Time Frame: approximately 3 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteer
Drug: RO5428029
Single oral dose
  • Experimental: A food
    Intervention: Drug: RO5428029
  • Experimental: B without food
    Intervention: Drug: RO5428029
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01345942
PP25583
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP