A Pharmacodynamic and Pharmacokinetic Study of RO5508887 in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 8/3/2016 |
Start Date: | May 2012 |
End Date: | October 2012 |
A Single-Center, Randomized, Investigator/Subject-Blind, Single Dose, Placebo-Controlled, Parallel Group Study to Investigate the Pharmacodynamic and Pharmacokinetic Behavior of RO5508887 in Plasma and Cerebral Spinal Fluid Following Oral Administration in Healthy Volunteers
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the
pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.
Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or
placebo. In-unit period is 6 days.
pharmacodynamics and pharmacokinetics of RO5508887 in healthy volunteers.
Subjects will be randomized in cohorts to receive single oral doses of either RO5508887 or
placebo. In-unit period is 6 days.
Inclusion Criteria:
- Healthy male subjects, 18 to 65 years of age, inclusive. Healthy status is 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) 18 to 30 kg/m2 inclusive
- Must agree to use a barrier method of contraception during the treatment period and
for at least 30 days after the last dose of study drug
- Donation of blood over 500 mL within 6 weeks before drug administration
Exclusion Criteria:
- Concomitant disease or condition or treatment that could interfere with the conduct
of the study or would, in the opinion of the investigator, pose an unacceptable risk
to the subject in this study
- Allergy to lidocaine
- Suspicion of regular consumption of drug of abuse
- Regular smoker (> 5 cigarettes, > 1 pipeful or > 1 cigar per day)
- Positive for hepatitis B, hepatitis C or HIV 1 or 2 infection
- Participation in an investigational drug or device study (last administration of
study drug or installation of device) within 6 weeks before RO5508887 administration
and within 5 mean half-lives of receiving previous investigational drug before
RO5508887 administration. In addition, subject cannot participate unless completely
recovered from previous invasive or study procedure
- Donation of blood over 500 mL within 6 weeks before drug administration
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