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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01345942
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RO5428029 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : May 2011
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: A food Drug: RO5428029
Single oral dose

Experimental: B without food Drug: RO5428029
Single oral dose

Primary Outcome Measures :
  1. Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Safety: Incidence of adverse events [ Time Frame: approximately 3 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01345942

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United States, Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT01345942    
Other Study ID Numbers: PP25583
First Posted: May 2, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016