A Phase 1 Study of RO6806127 in Healthy Male Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteer
In brief
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 food on the relative bioavailability of a single oral dose of RO6806127 in a separate group of healthy male participants. The relationship between drug exposure and tolerability will be explored.
Key facts
- Study ID
- NCT02196636
- Run by
- Hoffmann-La Roche
- People needed
- 37
- Starts
- 2014-07-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Healthy male participants aged 18 to 45 years, inclusive
- A BMI between 18 to 30 kg/m2, inclusive
- Agreement to use highly effective contraception
You may not qualify if…
- 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
Where it is running
- Study site — Marlton, New Jersey, United States
Full record on ClinicalTrials.gov
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