The main purpose of the study is to investigate the safety and tolerability of MDV1634. Additional objectives of the study are to assess how quickly and to what extent MDV1634 is absorbed and eliminated from the body (pharmacokinetics), and theā¦
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the safety and tolerability of MDV1634 in patients with Parkinson*s
disease.
Secondary outcome
To evaluate the pharmacokinetics of MDV1634 in patients with Parkinson*s disease
To evaluate the effect of MDV1634 on biomarkers of Parkinson*s disease.
To evaluate the relationship between MDV1634 pharmacokinetics and biomarkers
and/or safety outcomes in patients with Parkinson*s disease.
Background summary
MDV1634 is an investigational compound under study as a potential
disease-modifying therapy for Parkinson*s disease. Current drug treatments for
Parkinson*s disease do not cure the disease and are largely aimed at reducing
symptoms by increasing dopamine in the central nervous system (such as
levodopa). MDV1634 is being studied to see if it has neuroprotective properties
in Parkinson*s patients and hence slows progression of the disease.
Study objective
The main purpose of the study is to investigate the safety and tolerability of
MDV1634. Additional objectives of the study are to assess how quickly and to
what extent MDV1634 is absorbed and eliminated from the body
(pharmacokinetics), and the effect of the compound on disease indicators
(biomarkers) will be explored.
Study design
This is a Phase 1, randomized, double-blind, placebo-controlled study in
patients with Parkinson*s disease. The study will evaluate the safety and
tolerability of MDV1634 administered for 21 days at different dose levels in
patients with Parkinson*s disease.
Intervention
MDV1634 or placebo.
Study burden and risks
All drugs cause side effects; the extent to which this occurs differs between
drugs. A total of 109 subjects including healthy volunteers and patients with
Parkinson*s disease have received one or more doses of MDV1634. MDV1634 was
generally well tolerated in these studies. The most frequently reported
complaints were headache, diarrhea and dizziness. MDV1634 has the potential to
lower blood pressure, but this has not been observed in any completed studies.
Since the study drug will be administered for only 3 weeks, no significant
health benefits are expected for participants in this study.
Market Street, 36th Floor 525
San Francisco CA 94105
US
Market Street, 36th Floor 525
San Francisco CA 94105
US
Listed location countries
Age
Inclusion criteria
Male and female volunteers
Parkinson disease
30-75 years of age
BMI 18-35 kg/m2, inclusive
Exclusion criteria
CYP2D6 genotype indicating poor or intermediate metabolizer status; Montreal Cognitive Assessment score < 24; hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 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 | EUCTR2014-004705-33-NL |
CCMO | NL53128.056.15 |