Status:
COMPLETED
A Phase 1 Study of RO6806127 in Healthy Male Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This two-part study will assess the safety and tolerability of single ascending oral doses of RO6806127 in a group of healthy male participants and investigate the effect of high fat and high caloric ...
Eligibility Criteria
Inclusion
- Healthy male participants aged 18 to 45 years, inclusive
- A BMI between 18 to 30 kg/m2, inclusive
- Agreement to use highly effective contraception
Exclusion
- Clinically significant abnormalities in laboratory test results
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer or cirrhosis
- Significant disorders of the central nervous system, including psychiatric disorders, behavioral disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson, anxiety, any personal or familial history of seizures, epilepsy or other convulsive condition, previous significant head trauma, or other factors predisposing to seizures
- Use of any prohibited medications and food before study start and during the study
- Dietary restrictions that would prohibit the consumption of standardized meals
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT02196636
Start Date
July 1 2014
End Date
January 1 2015
Last Update
November 2 2016
Active Locations (1)
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1
Marlton, New Jersey, United States, 08053