Status:
COMPLETED
A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will ...
Eligibility Criteria
Inclusion
- Healthy Chinese male and female volunteers, 18 to 45 years of age inclusive at time of screening
- Healthy status is defined by absence of evidence of any active or chronic disease or disorder following a detailed medical and surgical history and a complete physical examination
- Body mass index (BMI) 19 to 28 kg/m2 inclusive
Exclusion
- Pregnant or currently lactating females
- History of any clinically relevant disorder
- Any history of depressive episodes or treatment with antidepressants
- History of drug abuse within the past 2 years or positive results for drugs of abuse at screening or Day -1
- Alcohol dependence or history of this within the past 2 years or positive results for alcohol breath test at screening or Day -1
- Positive for HIV, hepatitis B or hepatitis C infection
- Regular smoker with consumption of more than 10 cigarettes a day or equivalent amount of tobacco
- Participation in a clinical study with an investigational drug or device within the last 3 months prior to dosing
- Medical history of significant drug allergies
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01433575
Start Date
September 1 2011
End Date
November 1 2011
Last Update
November 2 2016
Active Locations (1)
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1
Beijing, China, 100083