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

Healthy Volunteer Clinical Trial

Official title:

An Open-Label, Three-Period, Fixed Sequence Study to Investigate the Effect of Multiple Oral Doses of Rifampin, a Potent Cytochrome P450 3A Inducer, on the Single Dose Pharmacokinetics of RO5424802 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940510
• Other study ID #: NP29042
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2013
• Last updated: July 1, 2016
• Start date: October 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5424802
Single dose without (Day 1) and with (Day 17) co-administration of rifampin
• rifampin
Multiple doses Days 8-16 and Days 17-20

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of multiple doses of rifampin on single dose pharmacokinetics of RO5424802 in healthy subjects: Area under the concentration-time curve (AUC)		Pre-dose and up to 96 hours post-dose	No
Primary	Effect of multiple doses of rifampin on the single dose pharmacokinetics of RO5424802 in healthy volunteers: Maximum plasma concentration (Cmax)		Pre-dose and up to 96 hours post-dose	No
Secondary	Effect of multiple doses of rifampin on the pharmacokinetics of the major metabolite of RO5424802, M4: Cmax/AUC		Pre-dose and up to 96 hours post-dose	No
Secondary	Safety and tolerability of single doses of RO5424802, alone and in co-administration with rifampin: Incidence of adverse events		up to 31 days	No