No registrations found.
ID
Source
Brief title
Health condition
Parkinson's disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety and tolerability, PK and PD
Secondary outcome
NA
Background summary
YTX-7739 is a novel, orally active inhibitor of SCD enzymatic activity.
Here, we aim to explore the safety, tolerability, pharmacokinetic and pharmacodynamic properties of YTX-7739 in healthy adult volunteers (part A) as a prelude to further study this molecule as a potential disease modifying therapy for Parkinson’s disease and related neurological disorders. In part B, we aim to assess the effect of food on the pharmacokinetics of YTX-7739.
Study objective
Here, we aim to explore the safety, tolerability, pharmacokinetic and pharmacodynamic properties of YTX-7739 in healthy adult volunteers (part A) as a prelude to further study this molecule as a potential therapy for Parkinson’s disease. In part B, we aim to assess the effect of food on the pharmacokinetics of YTX-7739.
Study design
Screening, Day -1, Day 1, Day 2, Day 5, Day 7, Follow Up by phone.
Intervention
YTX-7739 10mg, 30mg, 100mg, 250mg, 500mg and placebo
Inclusion criteria
1. Healthy male and female subjects 18-45 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;
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 all study restrictions.
Exclusion criteria
2. Clinically significant findings, as judged by the investigator, as determined by medical history taking, physical examination, ECG and vital signs;
3. Subjects with a borderline QTcF of > 450 ms for males and > 470 ms for females at screening or a history of long QT syndrome;
4. Hemodynamic status at screening: systolic blood pressure <100 or >160 mmHg, diastolic blood pressure <60 or >95 mmHg or heart rate <45 or >100 bpm
5. Any current, clinically significant, known medical condition, as judged by the investigator;
6. Pregnant, lactating or breast-feeding women;
7. Have a urine drug screen detecting illicit drug(s) of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC) or positive alcohol breath test at screening.
8. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at screening;
10. History or clinical evidence of alcoholism or drug abuse;
15. Subjects of childbearing potential who are unwilling or unable to use a highly effective method of barrier contraception for the duration of the study and for at least 90 days after their last dose of study treatment.
16. All males who are unwilling to practice effective contraception and abstain from sperm donation during the study and who are not willing and able to continue contraception and abstain from sperm donation for at least 90 days after their last dose of study treatment.
17. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8258 |
| CCMO | NL71070.056.19 |
| OMON | NL-OMON49863 |