A Phase 1 Study of RO6806127 in Healthy Male Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: Placebo

Drug: RO6806127

Study type

Interventional

Funder types

Industry

Identifiers

NCT02196636

2014-001019-38 (EudraCT Number)

BP29276

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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