Status:
COMPLETED
A Study of Three Modified-Release Formulations of RO4917523 in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequenc...
Eligibility Criteria
Inclusion
- Healthy male and female volunteers, 18 - 55 years of age inclusive Healthy status will be defined by absence in evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive, and body weight of at least 50 kg
- Females of child-bearing potential must agree to use effective contraception as defined by protocol
- Non-smoker for at least 90 days prior to dosing on Day 1
Exclusion
- History or presence of a clinically significant psychiatric condition as defined by protocol
- Participation in an clinical study with an investigational drug within 60 days or 5 times the half-life (whichever is longer) preceding first administration of study drug. Participation in more than 3 other drug studies within 10 months preceding first administration of study drug.
- Clinically significant disease or disorder
- Personal or family history of long QT syndrome or sudden death
- Any suspicion or history of alcohol and/or other substance abuse or dependence in the last 6 months
- Subject likely to need concomitant medication during the study (including for dental conditions), except for hormonal contraception or HRT
- Pregnant or lactating women, or women who intend to become pregnant during the course of the study
- Positive for hepatitis B, hepatitis C or HIV infection
- Any confirmed significant allergic reactions against any drug, or multiple allergies
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01873508
Start Date
June 1 2013
End Date
August 1 2013
Last Update
September 10 2015
Active Locations (1)
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1
Marlton, New Jersey, United States, 08053