Recruiting NCT07675590
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TIX100, Placebo.
- Who it may be relevant to
- Registry conditions: Health Adult Subjects, Obesity & Overweight. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single Center, Multiple Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
Overview
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.
Interventions
- Drug TIX100
oral administration over 28 days - Drug Placebo
oral administration over 28 days
Primary outcome measures
- Safety and Tolerability [Time frame: Day 1 to Day 35]
Secondary outcome measures (1)
- Pharmacokinetic: Area Under Concentration (AUC) [Time frame: Day 1 and Day 28]
Eligibility criteria
Inclusion criteria
- Subjects 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 subjects with female partners of childbearing potential must agree to utilize condoms for the duration of the study.
- 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.
- 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).
- Body mass index (BMI) 25 - 34.9 kg/m2
- HbA1c <6.5%
- Willingness to fully comply with protocol.
Exclusion criteria
- 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, structural heart disease, or a family history of LQTS.
- Participation in an investigational drug trial within three months prior to dosing in the present study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- ProSciento, INC — Chula Vista
Identifiers
NCT: NCT07675590 · TIX100-02