A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMIC EFFECTS, SAFETY AND TOLERABILITY OF REPEATED DOSING OF RO5459072 IN HEALTHY SUBJECTS

A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMIC EFFECTS, SAFETY AND TOLERABILITY OF REPEATED DOSING OF RO5459072 IN HEALTHY SUBJECTS - RO5459072 MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42481

Enrollment

Registered

2015-06-18

Start date

2015-08-10

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

Lupus

Interventions

This study will be performed in maximally 36 healthy volunteers, divided over up to 4 groups (Groups A, B, C and D). Each group will contain 9 volunteers. The subjects can participate in one group o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy male and female subjects 18 to 60 years old, iinclusive BMI between 18.0 and 30.0 kg/m^2

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
To investigate the effects of RO5459072 on pharmacodynamic measures of cathepsin S activity and immune function.	—

Secondary

Measure	Time frame
* To investigate the safety and tolerability of repeated dosing with RO5459072. * To characterize the steady state pharmacokinetics of RO5459072 and assess time dependency. * To characterize the relationship between RO5459072 exposure and pharmacodynamic parameters * To explore the influence of intrinsic factors and alternative dosing regimens on the pharmacokinetics and pharmacodynamic effects of RO5459072. * To collect samples for exploratory metabolite profiling.	—

Measure

Time frame

* To investigate the safety and tolerability of repeated dosing with RO5459072. * To characterize the steady state pharmacokinetics of RO5459072 and assess time dependency. * To characterize the relationship between RO5459072 exposure and pharmacodynamic parameters * To explore the influence of intrinsic factors and alternative dosing regimens on the pharmacokinetics and pharmacodynamic effects of RO5459072. * To collect samples for exploratory metabolite profiling.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)