A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Orally Administered TIX100 in Healthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTIXiMED, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Subjects aged 18-70 years, both genders.
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
TIX100
Drugoral administration over 28 days
Placebo
Drugoral administration over 28 days
Treatment groups
18 Participants
are divided into 4 treatment groupsGroup A: TIX100 40mg BIDActive comparator 1 intervention
Group B: TIX100 80mg BIDActive comparator 1 intervention
Group C: TIX100 120MG BIDActive comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and Tolerability
* Number of subjects with Treatment-Emergent Adverse Events (TEAEs) * Number of subjects with clinically significant TEAEs (Physical Examination, Vital Signs, ECG)
Time frame
Day 1 to Day 35Secondary outcomes
1
Pharmacokinetic: Area Under Concentration (AUC)
To determine the area under concentration (AUC) of multiple oral doses of TIX100 in otherwise healthy overweight/obese subjects
Time frame
Day 1 and Day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov