Healthy
Conditions
Keywords
TIX100, TIXiMED, inhibitor of thioredoxin-interacting protein
Brief summary
A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
Interventions
DRUGTIX100, an orally available inhibitor of thioredoxin-interacting protein
TIX100, an orally available inhibitor of thioredoxin-interacting protein
DRUGPlacebo
placebo
Sponsors
TIXiMED, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects aged 18-70 years, both genders. 2. Healthy as determined by a physician, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory function. History must comply with the following: 1. Absence of clinically significant illness or surgery within the preceding 12 weeks. 2. Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease. 3. Male subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study. 4. Female subjects of child-bearing potential with negative urine pregnancy tests and who agree to use double-barrier contraception during the study. The primary contraception may be either hormonal implant or hormonal or non-hormonal intrauterine device, and the secondary (barrier) method of contraception with condom and/or with spermicide. 5. Female subjects of non-child-bearing potential (i.e. tubal ligation, hysterectomy, or postmenopausal). 6. Body mass index (BMI) 18.5 - 29.9 kg/m2 7. HbA1c \<6.0%
Exclusion criteria
1. History of excessive alcohol use (defined as \>21 drinks per week for males and \>14 drinks per week for females), recreational drug use or drugs of abuse within the past three months, or failure on urinary drug screen. 2. Pregnant or breastfeeding within six months of screening assessment. 3. Substantial changes in eating habits or exercise routine within the preceding three months. 4. Evidence of eating disorders. 5. \>5% weight change in the past three months. 6. Bariatric surgery within the past five years. 7. Significant renal impairment (eGFR \<60 mg/mL/1.73m2). 8. Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements. 9. Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression). 10. Use of drugs approved for the treatment of obesity. 11. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests. 12. A baseline prolongation of QT/QTc interval after repeated measurements of \>450 ms; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of LQTS. 13. Participation in an investigational drug trial within three months prior to dosing in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Day 7 |
| Number of participants with laboratory analyte results above upper limit of normal. | Day 7 |
| Number of participants with vital sign results considered clinically significant by the investigator | Day 7 |
| Number of participants with ECG results considered clinically significant by the investigator | Day 7 |
| Number of participants with physical examination findings considered clinically significant by the investigator | Day 7 |
Countries
United States
Outcome results
None listed