Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
20–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy male and female adults, 20 to 55 years of age, inclusive
Body mass index (BMI) 18 - 30 kg/m2 inclusive
Non-smoker, or previous smoker who discontinued smoking \>/= 6 month prior to study entry
Japanese subjects must be first generation: born in Japan, not having lived outside Japan \>5 years, able to trace maternal and paternal Japanese ancestry
Female subjects of childbearing potential and male subjects and their partners of childbearing potential must agree to use two forms of contraception
Agree to abstain from alcohol consumption and from strenuous exercise up to 3 days before dosing and throughout study (including the follow-up visit)
You may not be if
Positive pregnancy test
Males whose female partner is pregnant or trying to become pregnant
Positive urine test for drugs of abuse
Positive for alcohol
Positive result on hepatitis B, hepatitis C, or HIV test
Clinically significant disease or abnormalities in laboratory parameters
Participation in an investigational drug, biologic or device study within 3 months before study drug administration
Donation or loss of any blood over 450 mL within 3 months before study drug administration
