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Tests treatment safety and results for Health Adult Subjects
Official title A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
ClinicalTrials.gov ID: NCT07675590
What this study is testing
What is TIX100?
TIX100 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for health adult subjects.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- people aged 18-70 years, both genders.
- Healthy as determined by the Investigator, based on history, medical examination, vital signs, laboratory tests, cardiac monitoring and respiratory...
- Absence of clinically significant illness or surgery within the preceding 12 weeks.
- Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric...
- Male people with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
You likely can't join if
- 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...
- Pregnant or breastfeeding within six months of screening assessment.
- Substantial changes in eating habits or exercise routines within the preceding three months.
- Evidence of eating disorders.
- \>5% weight change in the past three months.
- Bariatric surgery within the past five years.
See the full eligibility criteria
- people aged 18-70 years, both genders.
- 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:
- Absence of clinically significant illness or surgery within the preceding 12 weeks.
- Absence of clinically significant history of neurological, endocrine, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and/or metabolic disease.
- Male people with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
- Female people 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...
- Female people of non-child-bearing potential (i.e. bilateral tubal ligation (BTL), bilateral tubal occlusion (BTO), bilateral salpingectomy, hysterectomy, partial hysterectomy, bilateral oophorectomy, or postmenopausal...
- Body mass index (BMI) 25 - 34.9 kg/m2
- HbA1c \<6.5%
- Willingness to fully comply with protocol.
- 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.
- Pregnant or breastfeeding within six months of screening assessment.
- Substantial changes in eating habits or exercise routines within the preceding three months.
- Evidence of eating disorders.
- \>5% weight change in the past three months.
- Bariatric surgery within the past five years.
- Significant renal impairment (eGFR \<60 mL/min/1.73m2).
- Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
- Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
- Use of prescription medications during screening and duration of the trial.
- Use of drugs approved for the treatment of obesity.
- Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
- 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...
- Participation in an investigational drug trial within three months prior to dosing in the present study.
The study team makes the final eligibility decision.
Where it's taking place
- Chula Vista, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chula Vista, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.