A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
A Single Center, Multiple Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 28 days
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Randomized, Placebo-controlled Study to determine the safety and tolerability of multiple oral doses of TIX100 administered daily for 28 days to otherwise healthy overweight/obese subjects."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of TIX100 pills taken daily for 28 days, how well people tolerate them, and how the body handles the drug. It is for otherwise healthy adults ages 18–70 who are overweight or have obesity. People are assigned by chance to receive TIX100 or a placebo, a pill with no active study drug.
Randomized, Placebo-controlled Study to determine the safety and tolerability of multiple oral doses of TIX100 administered daily for 28 days to otherwise healthy overweight/obese subjects.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18–70, of any gender.
- Healthy based on the study doctor's exam, health history, blood tests, and heart and breathing checks.
- No major illness or surgery in the past 12 weeks, and no history of major diseases.
- Body mass index (BMI), a measure of weight compared with height, of 25–34.9.
- HbA1c, a blood test showing average blood sugar, below 6.5%.
- Men with partners who could become pregnant must use condoms during the study.
- Women who could become pregnant must have negative urine pregnancy tests and use two birth control methods as required by the study. Women who cannot become pregnant due to surgery or menopause may also join.
- Willing to follow all study rules.
Who can't join
- Heavy alcohol use: more than 21 drinks a week for men or 14 for women; recreational drug use or drug misuse in the past 3 months; or a failed urine drug test.
- Pregnant or breastfeeding within 6 months before screening.
- Major changes in eating or exercise, or a weight change over 5%, in the past 3 months; an eating disorder; or weight-loss surgery in the past 5 years.
- Poor kidney function (eGFR below 60) or liver blood tests repeatedly more than twice the normal upper limit.
- A disease that affects how the body uses food or affects eating behavior, or another major problem found on the study exam or lab tests.
- Use of prescription medicines during screening or the study, or use of medicines approved for obesity.
- Certain abnormal heart rhythm tests; a history of unexplained fainting, cardiac arrest, unexplained abnormal heart rhythms, or heart structure problems; or a family history of long QT syndrome, a heart rhythm condition.
- Taking part in another study of an experimental drug within 3 months before receiving this study's drug.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Subjects aged 18-70 years, both genders. 2. Healthy as determined by the Investigator, 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 oral contraceptives, 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. bilateral tubal ligation (BTL), bilateral tubal occlusion (BTO), bilateral salpingectomy, hysterectomy, partial hysterectomy, bilateral oophorectomy, or postmenopausal, defined as no menses for 12 months without an alternative medical cause). 6. Body mass index (BMI) 25 - 34.9 kg/m2 7. HbA1c \<6.5% 8. Willingness to fully comply with protocol. 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 routines 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 mL/min/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 prescription medications during screening and duration of the trial. 11. Use of drugs approved for the treatment of obesity. 12. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests. 13. A baseline prolongation of QT/QTcF interval after repeated measurements of \>450 ms for men and \>470 for women; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of LQTS. 14. Participation in an investigational drug trial within three months prior to dosing in the present study.
Study sites (1)
CA
- ProSciento, INC · Chula Vista, CA 91911More trials in Chula Vista