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Completed

NCT Number: NCT01345942

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Antonio, Texas, 78209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5428029

Drug

Single oral dose

Primary outcomes

  1. Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration

    Time frame: 72 hours

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 3 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 2, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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