Recruitment

Recruitment Status
Completed
Estimated Enrollment
22

Inclusion Criterias

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
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
Nonsmoking subjects and former smoking subjects (who have not smoked for the past six months before first dosing)
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

Exclusion Criterias

Positive for hepatitis B, hepatitis C, or HIV infection
Suspicion of regular consumption of drug(s) of abuse including marijuana
Positive urine test for drugs of abuse, alcohol, or cotinine test at screening or prior to admission to the study unit
...
Positive for hepatitis B, hepatitis C, or HIV infection
Suspicion of regular consumption of drug(s) of abuse including marijuana
Positive urine test for drugs of abuse, alcohol, or cotinine test at screening or prior to admission to the study unit
Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
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
Women of childbearing potential, pregnant or lactating women, or males with female partners who are pregnant or lactating
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)
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
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
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

Summary

Conditions
Healthy Volunteer
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

Inclusion Criterias

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
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
Nonsmoking subjects and former smoking subjects (who have not smoked for the past six months before first dosing)
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

Exclusion Criterias

Positive for hepatitis B, hepatitis C, or HIV infection
Suspicion of regular consumption of drug(s) of abuse including marijuana
Positive urine test for drugs of abuse, alcohol, or cotinine test at screening or prior to admission to the study unit
...
Positive for hepatitis B, hepatitis C, or HIV infection
Suspicion of regular consumption of drug(s) of abuse including marijuana
Positive urine test for drugs of abuse, alcohol, or cotinine test at screening or prior to admission to the study unit
Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
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
Women of childbearing potential, pregnant or lactating women, or males with female partners who are pregnant or lactating
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)
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
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
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

Locations

Austin, Texas, 78744
Austin, Texas, 78744

Tracking Information

NCT #
NCT01940510
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche