Recruitment

Recruitment Status
Completed
Estimated Enrollment
32

Inclusion Criterias

Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug
Female subject must be post-menopausal or surgically sterile
Body mass index (BMI) 18 to 30 kg/m2 inclusive
...
Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug
Female subject must be post-menopausal or surgically sterile
Body mass index (BMI) 18 to 30 kg/m2 inclusive
Adult male and female volunteers, 18 - 64 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination

Exclusion Criterias

Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
History of any clinically significant disease or disorder
...
Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
History of any clinically significant disease or disorder
Suspicion of regular consumption of drug of abuse
Clinically significant abnormalities in laboratory test results
History of clinically significant hypersensitivity or allergic drug reactions
Positive for hepatitis B, hepatitis C or HIV infection
Participation in an investigational drug or device study within 90 days prior to screening

Summary

Conditions
Healthy Volunteer
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)

Participation Requirements

Age
Between 18 years and 64 years
Gender
Both males and females

Inclusion Criterias

Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug
Female subject must be post-menopausal or surgically sterile
Body mass index (BMI) 18 to 30 kg/m2 inclusive
...
Male subjects with female partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for at least 30 days after the last dose of study drug
Female subject must be post-menopausal or surgically sterile
Body mass index (BMI) 18 to 30 kg/m2 inclusive
Adult male and female volunteers, 18 - 64 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination

Exclusion Criterias

Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
History of any clinically significant disease or disorder
...
Regular smoker (>5 cigarettes, >1 pipeful or >1 cigar per day)
Concomitant disease or condition that could interfere with, or the treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
History of any clinically significant disease or disorder
Suspicion of regular consumption of drug of abuse
Clinically significant abnormalities in laboratory test results
History of clinically significant hypersensitivity or allergic drug reactions
Positive for hepatitis B, hepatitis C or HIV infection
Participation in an investigational drug or device study within 90 days prior to screening

Locations

Zuidlaren, 9471 GP
Zuidlaren, 9471 GP

Tracking Information

NCT #
NCT01864226
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche