A single-center, randomized, double-blind, placebo-controlled, single ascending dose study to investigate the pharmacokinetics, pharmacodynamic effects, safety and tolerability of single doses of RO5459072 in healthy volunteers.

A single-center, randomized, double-blind, placebo-controlled, single ascending dose study to investigate the pharmacokinetics, pharmacodynamic effects, safety and tolerability of single doses of RO5459072 in healthy volunteers. - RO5459072 Single Ascending Dose Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41854

Enrollment

Registered

2014-11-05

Start date

2014-12-07

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 16 healthy volunteers, divided over 2 groups, which will participate in an alternating design. Volunteers in Group A will participate in the 1st, 3rd, 5th and 7th per

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy subjects 18 and 60 years of age, inclusive BMI 18 - 30 kilogram/meter2 non smokers *

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 investigate the safety and tolerability of RO5459072 in healthy volunteers.	—

Secondary

Measure	Time frame
Secondary: * To investigate the effects of RO5459072 on pharmacodynamic measures of cathepsin S activity. * To characterize the relationship between RO5459072 exposure and pharmacodynamic measures of cathepsin S activity. * To characterize the single dose pharmacokinetics of RO5459072 and assess dose proportionality. * To explore the influence of genotype on the pharmacokinetic and pharmacodynamic effects of RO5459072. * To collect samples for exploratory metabolite profiling.	—

Measure

Time frame

Secondary: * To investigate the effects of RO5459072 on pharmacodynamic measures of cathepsin S activity. * To characterize the relationship between RO5459072 exposure and pharmacodynamic measures of cathepsin S activity. * To characterize the single dose pharmacokinetics of RO5459072 and assess dose proportionality. * To explore the influence of genotype on the pharmacokinetic 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)