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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: November 3, 2014
Last verified: November 2014
  Purpose

This open label, two period, crossover study will evaluate the safety and the ef fect of food on the pharmacokinetics of RO5428029 in healthy volunteers. In a cr ossover design, healthy subjects will be randomized to receive a single oral dos e of RO5428029 with or without food, with a washout period of at least 7 days be tween dosing and a follow-up of 7 to 10 days after last dose. Anticipated time o n study will be up to 21 days.


Condition Intervention Phase
Healthy Volunteer
Drug: RO5428029
Phase 1

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A food Drug: RO5428029
Single oral dose
Experimental: B without food Drug: RO5428029
Single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345942

Locations
United States, Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01345942     History of Changes
Other Study ID Numbers: PP25583
Study First Received: April 29, 2011
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 20, 2014