TIX100 Safety Study in Healthy Volunteers

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: TIXiMED, Inc.

Must not be taking: Obesity drugs

Disqualifiers: Excessive alcohol, Recreational drugs, Renal impairment, Liver dysfunction, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

35 Participants Needed

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. ^{1 2 3 4 5}

Eligibility 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.

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

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

Treatment Details

Interventions

• TIX100

Trial Overview 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.

Participant Groups

Group I: TIX100 200 mg Active Control 1 Intervention

Group II: TIX100 20 mg Active Control 1 Intervention

Group III: TIX100 60 mg Active Control 1 Intervention

Group IV: TIX100 100 mg Active Control 1 Intervention

Group V: TIX100 160 mg Active Control 1 Intervention

Group VI: placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

TIXiMED, Inc.

Lead Sponsor

Trials

1

Recruited

40+

Findings from Research

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

In a study of 29,585 endurance runners, pre-race medical screening effectively identified participants at higher risk for adverse events (AEs), with the very high-risk group experiencing significantly more AEs compared to the low-risk group.

The findings suggest that risk stratification can help predict who may face challenges during a race, although further research is needed to determine how screening can reduce these risks in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-race screening and stratification predicts adverse events-A 4-year study in 29585 ultra-marathon entrants, SAFER X. Sewry, N., Schwellnus, M., Borjesson, M., et al.[2020]

A review of 73 migraine drug trials published between 2010 and 2015 found that while a majority reported adverse events, only 41% included this information in their abstracts, highlighting a gap in transparency.

The study emphasizes the need for all randomized controlled trials on migraine treatments to consistently report adverse events in their abstracts to better assess the safety and tolerability of these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. Tfelt-Hansen, P., Lindqvist, JK., Do, TP.[2019]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

In a survey of 459 members of the British Pharmacological Society, it was found that drugs were administered to 8163 healthy volunteers, with only 6.9% experiencing minor adverse effects and 0.04% facing potentially life-threatening effects, indicating a very low risk associated with these studies.

Among 7607 healthy student volunteers, only 6.0% reported minor adverse effects during drug administration for educational purposes, with no severe adverse effects noted, reinforcing the overall safety of drug administration in healthy volunteer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Orme, M., Harry, J., Routledge, P., et al.[2019]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. [2018]

2. Denmark pubmed.ncbi.nlm.nih.gov

Pre-race screening and stratification predicts adverse events-A 4-year study in 29585 ultra-marathon entrants, SAFER X. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010-2015 on migraine drug treatments. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. [2019]