TIX100 Safety Study in Healthy Volunteers
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: TIXiMED, Inc.
Must not be taking: Obesity drugs
Disqualifiers: Excessive alcohol, Recreational drugs, Renal impairment, Liver dysfunction, others
Trial Summary
What is the purpose of this trial?A Single Center, Single Dose, Randomized, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires participants to be healthy without significant medical conditions or recent surgeries. It's best to discuss your specific medications with the trial team.
What safety data exists for TIX100 or similar treatments in healthy volunteers?
In a survey of drug administration to healthy volunteers, minor adverse effects were reported in about 6.9% of cases, with very few experiencing more severe effects, and no lasting harm was noted. This suggests that the risk in such studies is generally low.
12345Eligibility Criteria
This trial is for healthy adults aged 18-70 with a BMI of 18.5-29.9, no significant illnesses or surgeries in the last 12 weeks, and no history of neurological, cardiovascular, or other major diseases. Participants must not have used investigational drugs recently, abused substances, be pregnant/breastfeeding recently, or have had bariatric surgery within five years.Inclusion Criteria
Body mass index (BMI) 18.5 - 29.9 kg/m2
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: 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
I will use condoms during the study if my partner can have children.
+4 more
Exclusion Criteria
Participation in an investigational drug trial within three months prior to dosing in the present study
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
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive a single dose of TIX100 or placebo to evaluate safety, tolerability, and pharmacokinetics
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and pharmacokinetics after receiving the single dose
2-4 weeks
Participant Groups
The study tests TIX100's safety and how the body processes it compared to a placebo. It's given once to healthy volunteers who are randomly assigned to either receive TIX100 or a placebo in a controlled environment at one center.
6Treatment groups
Active Control
Placebo Group
Group I: TIX100 200 mgActive Control1 Intervention
Group II: TIX100 20 mgActive Control1 Intervention
Group III: TIX100 160 mgActive Control1 Intervention
Group IV: TIX100 60 mgActive Control1 Intervention
Group V: TIX100 100 mgActive Control1 Intervention
Group VI: placeboPlacebo Group1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ProSciento, Inc.Chula Vista, CA
Loading ...
Who Is Running the Clinical Trial?
TIXiMED, Inc.Lead Sponsor
References
Improving safety reporting from randomised trials. [2018]Randomised clinical trials offer a unique opportunity for capturing safety information under a controlled setting that minimises biases in the comparison of different therapeutic options. Nevertheless, empirical evidence across diverse medical fields suggests that the reporting of safety information in clinical trials is largely neglected and receives less attention compared with efficacy outcomes. An analysis of 192 randomised trials has shown that reasons for withdrawals due to toxicity were specified per study arm in only 46% of the trial reports. Adequate reporting of clinical adverse effects and laboratory-determined toxicity occurred in only 39 and 29% of the trials, respectively, even with lenient definitions of what constitutes adequate reporting. The use of standardised scales for adverse effects is a prerequisite for improved reporting on safety in randomised trials. Safety data need to be collected and analysed in a systematic fashion and active surveillance for toxicity during the conduct of a randomised trial is preferable to passive surveillance. Standardised reporting of safety data does not necessarily require extensive space to accomplish. It is essential to provide numerical data per study arm on each type of adverse effect along with a categorisation of the severity of the adverse effects with an emphasis on severe and life-threatening reactions. The severity grading must be referred to well-known standardised scales and new scales need to be carefully defined. Information on withdrawals due to toxicity is also important to report, along with the specific reasons leading to discontinuation. Tabulation of information may be helpful and rare or not previously reported adverse effects should be described in detail. The availability of newer options such as electronic publication, publication of raw databases, large database research, meta-analytic approaches, and prospective registration of clinical trials and of their databases may further improve the safety insights we can gain from randomised clinical trials.
Pre-race screening and stratification predicts adverse events-A 4-year study in 29585 ultra-marathon entrants, SAFER X. [2020]Pre-race screening and risk stratification in recreational endurance runners may predict adverse events (AEs) during a race.
Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. [2019]Background In 2008, the International Headache Society published guidelines on the "evaluation and registration of adverse events in clinical drug trials on migraine". They listed seven recommendations for reporting adverse events in randomized controlled trials on migraine. The present study aimed to evaluate adherence to these recommendations, and based on the results, to recommend improvements. Methods We searched the PubMed/MEDLINE database to identify controlled trials on migraine drugs published from 2010 to 2015. For each trial, we noted whether five of the recommended parameters were presented. In addition, we noted whether adverse events were reported in abstracts. Results We identified 73 trials; 51 studied acutely administered drugs and 22 studied prophylactic drugs for migraine. The number of patients with any adverse events were reported in 74% of acute-administration and 86% of prophylactic drug trials. Only 30 (41%) of the 73 studies reported adverse events with data in the abstracts, and 27 (37%) abstracts did not mention adverse events. Conclusion Adverse events, both frequency and symptoms, should be reported to allow a fair judgement of benefit/tolerability ratio when randomized controlled trials in migraine treatment are published. Clinically significant adverse events should be included in the abstract of every randomized controlled trial in migraine treatment.
Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]This report describes all clinical, laboratory and electrocardiographical adverse events detected in healthy volunteers in a phase-I centre over a 10-year period: 54 phase-I studies are involved, including 1015 healthy young volunteers (993 males) who received 1538 treatments (23 different active drugs or placebo) corresponding to 12143 days of follow-up. This updates a similar report published previously in the European Journal of Clinical Pharmacology.
Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. [2019]1. A survey has been conducted amongst 459 members of the Clinical Section of the British Pharmacological Society to ascertain facts about the administration of drugs to healthy volunteers over the period October 1986 to September 1987. 2. A response rate of 87.1% was obtained with 114 individuals being involved in healthy volunteer studies. After exclusion of duplicate returns from the same unit 98 questionnaires were analysed. 3. Drugs were given in the year under review to 8163 healthy volunteers for research purposes. Minor adverse effects were reported in 565 (6.9%), moderately severe adverse effects in 45 (0.55%) and potentially life threatening adverse effects in 3 (0.04%). No lasting sequelae were reported. 4. Drugs were given to 7607 healthy student volunteers as part of class teaching practicals. Minor adverse effects were reported in 6.0% of student exposures but no moderately severe or life threatening adverse effects were reported. 5. The risk involved in healthy volunteer studies is very small indeed but some suggestions are made as a result of the questionnaire to improve further the safety of these studies.