A single-center, randomized, double-blind, adaptive, parallel study to investigate the safety, tolerability, pharmacokinetics (Including the effect of food), and pharmacodynamics of RO6806127 in healthy male subjects.

A single-center, randomized, double-blind, adaptive, parallel study to investigate the safety, tolerability, pharmacokinetics (Including the effect of food), and pharmacodynamics of RO6806127 in healthy male subjects. - RO6806127 Single ascending dose and food effect study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41129

Enrollment

Registered

2014-06-13

Start date

2014-06-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

personality disorder

Interventions

The study will consist of 1 period during which the volunteer will receive a single dose of RO6806127 or placebo. Whether the volunteer will receive RO6806127 or placebo will be determined by chan

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male subject 18 and 45 years of age, inclusive BMI 18 - 30 kilograms/meter2

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
Primary: To assess the safety and tolerability of single ascending oral doses of RO6806127 in healthy male subjects and to determine, if achievable, the maximum tolerated dose (MTD). To investigate the single-dose oral pharmacokinetics (PK) of RO6806127 and its metabolite(s) as appropriate, in plasma and urine.	—

Secondary

Measure	Time frame
Part 1 Secondary: To screen for the presence of metabolites of RO6806127 in selected plasma and urine samples. To explore the relationship between exposure of RO6806127 and tolerability/pharmacodynamics. Part 2: Food Effect (FE) Study Secondary: To assess the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 administered to healthy male subjects.	—

Measure

Time frame

Part 1 Secondary: To screen for the presence of metabolites of RO6806127 in selected plasma and urine samples. To explore the relationship between exposure of RO6806127 and tolerability/pharmacodynamics. Part 2: Food Effect (FE) Study Secondary: To assess the effect of high fat and high caloric food on the relative bioavailability of a single oral dose of RO6806127 administered to healthy male subjects.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)