- To investigate the baseline profile and inter- and intra-subject within-day and between-day variability of the fatty-acid profiles including fatty-acid desaturation index (FA-DI) and PUFAs in the plasma of patients with Parkinson*s disease and…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Fatty-acid profiles of the following fatty acids:,
* Saturated fatty acids in plasma including but not limited to: C16:0, C18:0
* Unsaturated fatty acids (MUFAs and PUFAs) in plasma including but not limited
to: C16:1n7t, C16:1n9, C16:1n7, C18:1t, C18:1n9, C18:2n6t, C18:2n6, C18:3n6,
C20:1n9, C18:3n3, C20:2n6, C20:3n6, C20:4n6, C20:5n3, C24:1n9, C22:4n6,
C22:5n6, C22:5n3, C22:6n3
Fatty-acid desaturation index (FA-DI) in plasma will be calculated from the
respective fatty acid profiles:
* Ratio between C16:1 and C16:0
* Ratio between C18:1 and C18:0
Secondary outcome
NA
Background summary
Yumanity is developing YTX-7739, an orally active, small molecule stearyl-CoA
desaturase (SCD) inhibitor as a potential disease modifying therapy for
patients with Parkinson*s disease. The investigational drug will be used in the
CHDR1911 single dose study and subsequently in the CHDR1916 multiple dose
study. Concomitant with initiation of Phase I studies of YTX-7739 in healthy
volunteers, this exploratory study will evaluate fatty acid profiles in the
plasma of ten (10) patients with Parkinson*s disease and a cohort of ten (10)
age- and sex-matched, healthy control subjects. The aim of this study is to
examine baseline variability in C16 and C18 FA-DI and PUFAs, as well as broad
changes in fatty-acid profiles, across subjects and assess within day and
day-to-day variability in FA-DI and PUFAs within individual subjects over a
period of 3 days. In addition, this study will explore differences between
FA-DI and PUFAs in subjects with Parkinson*s disease as compared to healthy,
age-matched controls. The data from this exploratory study will be used to
determine the inter- and intra-subject variability of FA-DI and PUFAs and
define appropriate timepoints and sampling intervals for FA-DI and PUFA
determination in human subjects. Together, the results will inform design of
the multiple ascending dose study of YTX-7739 in healthy volunteers and
Parkinson*s patients.
Study objective
- To investigate the baseline profile and inter- and intra-subject within-day
and between-day variability of the fatty-acid profiles including fatty-acid
desaturation index (FA-DI) and PUFAs in the plasma of patients with Parkinson*s
disease and healthy, age- and sex-matched control subjects.
Study design
This is an exploratory biomarker study of fatty acid profiles in healthy
volunteers and individuals with Parkinson*s disease. A total of 20 subjects
will undergo plasma sampling up to six times a day for three days.
Study burden and risks
This study requires collection of blood samples. The burden for the volunteer
related to the study procedures is limited. All collections will be performed
in a state-of-the-art clinical unit and medically supervised by qualified
medical staff.
790 Memorial Drive, Suite 2C
Cambridge MA 02139
US
790 Memorial Drive, Suite 2C
Cambridge MA 02139
US
Listed location countries
Age
Inclusion criteria
1. Healthy male or female subjects 35-80 years of age, inclusive. Healthy
status is defined by absence of evidence of any active acute or chronic disease
or illness following a detailed medical and surgical history, a complete
physical examination including vital signs, 12-lead ECG, hematology, blood
chemistry and urinalysis; deemed by the investigator to be clinically
significant;
OR: Male or female subjects 40-75 years of age, with a confirmed diagnosis of
Parkinson*s disease (Hoehn and Yahr grade 1-4) inclusive;
2. Body mass index (BMI) between 18-35 kg/m2, inclusive, and with a minimum
weight of 50kg and maximum weight of 120kg;
3. Evidence of a personally signed, dated and witnessed informed consent
document indicating that the subject has been informed of all pertinent aspects
of the study;
4. Able and willing to give written informed consent and to comply with any and
all study restrictions.
Exclusion criteria
1. Legal incapacity or inability to understand or comply with the requirements
of the study;
2. Clinically significant findings as determined by medical history taking,
physical examination, ECG and vital signs, which, in the opinion of the
Investigator, does not allow study participation.
3. Any current, clinically significant, known medical condition other than
Parkinson*s disease. Patients with a diagnosis of other neurological diseases,
including Alzheimer*s disease, Huntington*s disease, vascular dementia,
epilepsy, etc., will not be eligible for this study.
4. Have a urine drug screen detecting illicit drug(s) of abuse (morphine,
benzodiazepines, cocaine, amphetamine, THC, methamphetamine, MDMA) or positive
alcohol breath test at screening, with exception of positive urine drug screens
caused by prescribed drugs, such as benzodiazepines for PD sleeping disorders;
5. Consume, on average, >8 units/day of (methyl)xanthines (e.g., coffee, tea,
cola, chocolate);
6. History or clinical evidence of alcoholism or drug abuse;
7. Smoking of >5 cigarettes/day or equivalent;
8. Use of prescription, illicit or herbal medication within 7 days of study
initiation, except for contraception or their current standard of care
medications for the treatment of parkinsonism;
9. Simultaneous participation in a clinical trial more than 4 times in the
previous year;
10. Being on a diet composed of relevantly altered amounts of fat, protein or
carbohydrates that may affect triglyceride and fatty acid levels.
11. Loss of blood * 500ml within 3 months before screening
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 |
|---|---|
| CCMO | NL71599.056.19 |