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

NCT01345942 | Completed Phase 1

• 1 other identifier: PP25583
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

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

  72 hours

Secondary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 3 weeks

Study Arms (2)

A food

EXPERIMENTAL

Drug: RO5428029

B without food

EXPERIMENTAL

Drug: RO5428029

Interventions

RO5428029 DRUG

Single oral dose

A food; B without food

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, 78209, United States

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)