A SINGLE ORAL ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO6836191 IN HEALTHY MALE VOLUNTEERS INCLUDING A SINGLE INTRAVENOUS DOSE OF RO6836191

A SINGLE ORAL ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO6836191 IN HEALTHY MALE VOLUNTEERS INCLUDING A SINGLE INTRAVENOUS DOSE OF RO6836191 - RO6836191 SAD + FE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40173

Enrollment

Registered

2013-10-16

Start date

2013-10-18

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

cardiovascular diseases high blood pressure

Interventions

Part 1: During the study the study medication will be given after a fasting period (no food or drinks) of at least 8 hours as a drinking solution at a volume of 50 to 100 milliliters. The bottle con

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 18 to 45 years of age, inclusive BMI between 18 to 30 kg/m2 inclusive healthy male volunteers

Exclusion criteria

Exclusion criteria: suffering from hepatitis B, hepatitis C or HIV/AIDS donation of blood over 450 mL within three months prior to screening Participation in another investigational drug or device study within 3 months prior to dosing

Design outcomes

Primary

Measure	Time frame
safety and tolerability pharmacokinetics of oral dosing pharmacodynamics	—

Secondary

Measure	Time frame
pharmacokinetics after IV dosing	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)