A Study of the Effect of Multiple Doses of Rifampin on the Single Dose Pharmacokinetics of RO5424802

NCT ID: NCT01940510

Last Updated: 2016-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-10-31

Brief Summary

This single center, open-label, 3-period, fixed-sequence study will evaluate the effect of multiple oral doses of rifampin on the pharmacokinetics of a single oral dose of RO5424802 in healthy volunteers. Subjects will receive a single dose of RO5424802 on Days 1 and 17 and rifampin daily from Days 8 to Day 20.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Healthy subjects

Group Type: EXPERIMENTAL

RO5424802

Intervention Type: DRUG

Single dose without (Day 1) and with (Day 17) co-administration of rifampin

rifampin

Intervention Type: DRUG

Multiple doses Days 8-16 and Days 17-20

Interventions

RO5424802

Single dose without (Day 1) and with (Day 17) co-administration of rifampin

Intervention Type: DRUG

rifampin

Multiple doses Days 8-16 and Days 17-20

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and female volunteers, 18 to 55 years of age inclusive. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a complete physical examination
• Body mass index (BMI) between 18 to 32 kg/m2 inclusive
• Nonsmoking subjects and former smoking subjects (who have not smoked for the past six months before first dosing)
• Female subjects must be surgically sterile or postmenopausal for the past year
• Male subjects and their partners of childbearing potential must be willing to use two effective methods of contraception, one of which must be a barrier method (e.g., condom) during the study and for 90 days after the last drug administration

Exclusion Criteria

• Women of childbearing potential, pregnant or lactating women, or males with female partners who are pregnant or lactating
• Positive urine test for drugs of abuse, alcohol, or cotinine test at screening or prior to admission to the study unit
• Suspicion of regular consumption of drug(s) of abuse including marijuana
• Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
• History (within three months of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study (including the washout period) until discharge
• Positive for hepatitis B, hepatitis C, or HIV infection
• Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to first dosing
• Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, absorption, distribution, metabolism or excretion of study medication, or that would, in the opinion of the PI, pose an unacceptable risk to the subject in this study
• History of hypersensitivity to any of the additives in the RO5424802 formulation (lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, sodium lauryl sulphate, magnesium stearate)
• Any history of hypersensitivity to or contraindication to the use of rifampin or other rifamycins or history of severe drug-related allergic reactions or hepatoxicity

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Austin, Texas, United States

Countries

United States

Other Identifiers

NP29042

Identifier Type: -

Identifier Source: org_study_id