A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single Ascending-Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics of RO5545965 Following Oral Administration in Healthy Subjects.

A Single-Center, Randomized, Investigator/Subject-Blind, Adaptive Single Ascending-Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food), and Pharmacodynamics of RO5545965 Following Oral Administration in Healthy Subjects. - RO5545965 SAD and FE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36943

Enrollment

Registered

2012-09-25

Start date

2012-10-10

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

psychiatric disorders Schizofrenia

Interventions

Part 1: subjects will receive a single dose of RO5545965 as an oral capsule Part 2: subjects will receive a single dose per period of RO5545965 as an oral capsule

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male subjects 18-45 yrs, inclusive BMI 18 to 30 kg/m2, inclusive Light smokers or non-smokers

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Participation in another drug study within 90 days before screening, as calculated from the day of follow-up from the previous study. Any donation of blood or significant blood loss within 3 months prior to first administration of the study drug.

Design outcomes

Primary

Measure	Time frame
Pharmacodynamics: Prolactin Pharmacokinetics: plasma/urine drug concentrations Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination, ESRS-A, DSST, Bond & Lader VAS	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)