A single-center, randomized, investigator/subject-blind, adaptive single-ascending dose (Part 1) and multiple-ascending dose (Part 2), placebo-controlled, parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6889450 following oral administration in healthy subjects.

A single-center, randomized, investigator/subject-blind, adaptive single-ascending dose (Part 1) and multiple-ascending dose (Part 2), placebo-controlled, parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6889450 following oral administration in healthy subjects. - RO6889450 SAD/MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44416

Enrollment

164

Registered

2016-02-11

Start date

2016-03-03

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

mental disorder characterized by abnormal social behavior and failure to recognize what is real

Interventions

Part 1: Group Day Treatment How often 1 1 5 milligrams RO6889450 or placebo Once 2 1 15 milligrams RO6889450 or placebo Once 3 1 50 milligrams RO6889450 or placebo Once 4 1 100 milligrams RO6889450 o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy male or female volunteers 18 - 45 years, inclusive BMI 18 - 30 kilogram/meter2, inclusive non-smoking

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
Part 1 SAD: To assess the safety and tolerability of RO6889450 after single oral ascending doses. Part 2 MAD: To assess the safety and tolerability of RO6889450 after multiple oral ascending doses.	—

Secondary

Measure	Time frame
Part 1 SAD: To investigate the pharmacokinetics of RO6889450 in plasma and urine after single oral ascending doses. To investigate the effect of RO6889450 on pharmacodynamic (PD) parameters after single oral ascending doses Part 2 MAD: To investigate the pharmacokinetics of RO6889450 in plasma and urine after multiple oral ascending doses (and its metabolite(s) if appropriate). To investigate the effect of RO6889450 on PD parameters after multiple oral ascending doses.	—

Measure

Time frame

Part 1 SAD: To investigate the pharmacokinetics of RO6889450 in plasma and urine after single oral ascending doses. To investigate the effect of RO6889450 on pharmacodynamic (PD) parameters after single oral ascending doses Part 2 MAD: To investigate the pharmacokinetics of RO6889450 in plasma and urine after multiple oral ascending doses (and its metabolite(s) if appropriate). To investigate the effect of RO6889450 on PD parameters after multiple oral ascending doses.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)