A Phase 1 Study of RO6806127 in Healthy Male Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 8/3/2016 |
| Start Date: | July 2014 |
| End Date: | January 2015 |
A Single-center, Randomised, Double-blind, Adaptative, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics or RO6806127 in Healthy Male Subjects
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
