In Part 1, a single dose will be administered of RO6889450 or placebo (same formulation but then without the active ingredient RO6889450). The purpose of Part 1 is to investigate how safe RO6889450 is and how well RO6889450 is tolerated. Part 1 will…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
RO6889450 is a new investigational compound that may eventually be used for the
treatment schizophrenia and bipolar disorders.
Study objective
In Part 1, a single dose will be administered of RO6889450 or placebo (same
formulation but then without the active ingredient RO6889450). The purpose of
Part 1 is to investigate how safe RO6889450 is and how well RO6889450 is
tolerated. Part 1 will also investigate how quickly and to what extent
RO6889450 is absorbed into, distributed in, and eliminated from the body (this
is called pharmacokinetics). In addition, the effect of RO6889450 on the body
using several tests (described later on in this document) will be investigated
(this is called pharmacodynamics).
In Part 2, multiple doses will be administered of RO6889450 or placebo (same
formulation but then without the active ingredient RO6889450). The purpose of
Part 2 is to investigate how safe RO6889450 is and how well RO6889450 is
tolerated. Part 2 will also investigate how quickly and to what extent
RO6889450 is absorbed into, distributed in, and eliminated from the body (this
is called pharmacokinetics). In addition, the effect of RO6889450 on the body
using several tests (described later on in this document) will be investigated
(this is called pharmacodynamics).
Study design
Part 1:
The actual study will consist of 1 period during which the volunteers will stay
in the clinical research center in Groningen for 6 days (5 nights): from the
afternoon of Day -2 (2 days before administration of the study compound) to the
morning of Day 4. This will be followed by 3 days (Days 6, 7 and 8) during
which they will visit the clinical research center in Groningen for a short
visit.
Part 2:
The actual study will consist of 1 period during which the volunteers will stay
in the clinical research center in Groningen for 20 days (19 nights): from the
afternoon of Day -3 (3 days before administration of the study compound) to the
morning of Day 17. This will be followed by 3 days (Days 19, 20 and 21) during
which they will visit the clinical research center in Groningen for a short
visit.
Intervention
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 or placebo Once
5 1 200 milligrams RO6889450 or placebo Once
6 1 300 milligrams RO6889450 or placebo Once
7 1 450 milligrams RO6889450 or placebo Once
Part 2:
Group Day Treatment
How often
1 1 to 14 X* milligrams RO6889450 or placebo Once daily
2 1 to 14 X* milligrams RO6889450 or placebo Once daily
3 1 to 14 X* milligrams RO6889450 or placebo Once daily
4 1 to 14 X* milligrams RO6889450 or placebo Once daily
5 1 to 14 X* milligrams RO6889450 or placebo Once daily
* The dose levels are not known yet and will be decided later based on
information from Part 1 of the study
Study burden and risks
Pain, minor bleeding, bruising, possibly an infection.
Grenzacherstrasse 124
Basel 4070
CH
Grenzacherstrasse 124
Basel 4070
CH
Listed location countries
Age
Inclusion criteria
healthy male or female volunteers
18 - 45 years, inclusive
BMI 18 - 30 kilogram/meter2, inclusive
non-smoking
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2015-005509-35-NL |
CCMO | NL56660.056.16 |