Randomized, double-blind, placebo-controlled single ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effects of YTX-7739, a novel oral inhibitor of Stearoyl-CoA-desaturases, in healthy volunteers

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 56

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, coagulation 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

1. Legal incapacity or inability to understand or comply with the requirements
of the study;
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;
9. Consumption of, on average, >8 units/day of (methyl)xanthines (e.g., coffee,
tea, cola, chocolate) and/or not able to refrain from use during each stay at
the CHDR clinic;
10. History or clinical evidence of alcoholism or drug abuse;
11. Smoking of >5 cigarettes/day or equivalent prior to screening and/or not be
able to refrain from smoking cigarettes during each stay at the CHDR clinic;
12. Use of prescription, illicit or herbal medication within 7 days or 5
half-lives prior to the first day of dosing, except contraception,and
paracetamol. Other current and recent (within 1 month prior to the screening)
treatments will be allowed, if judged by the investigator to have no clinical
relevance;
13. Participation in a clinical trial with an investigational drug or device
within 90 days of first dosing or more than 4 times in the previous year;
14. Loss or donation of blood * 500 mL within 3 months before screening;
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).
18. Part C, Cohort 7 only: History of spinal cord compression, any other
current abnormalities in the lumbar region (skin infection, structural
abnormalities in lower spine, etc.), or any other issue that, in the opinion of
the investigator, would make CSF collection unsafe
19. Positive SARS-CoV-2 PCR analysis prior to first dosing.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Considering the exploratory nature of this study, the primary endpoints will be<br /><br>the incidence and severity or AEs or treatment emergent AEs.</p><br>

Secondary Outcome Measures