Trial Outcomes & Findings for A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults (NCT NCT06243835)
NCT ID: NCT06243835
Last Updated: 2026-05-27
Results Overview
Treatment-emergent adverse events (TEAEs) were assessed starting after the first administration of investigational product until the final follow-up visit. A TEAE is defined as any AE that started or worsened in severity after the first dose of investigational product.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
From Day 1 to Day 7
Results posted on
2026-05-27
Participant Flow
Participant milestones
| Measure |
Kindolor Cohort 1
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test the Effects of Kindolor at Different Doses in Healthy Adults
Baseline characteristics by cohort
| Measure |
Kindolor Cohort 1
n=6 Participants
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=6 Participants
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 Participants
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
16 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=51 Participants
|
4 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
7 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
9 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=51 Participants
|
2 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=51 Participants
|
3 Participants
n=14 Participants
|
2 Participants
n=65 Participants
|
8 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
2 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=51 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=65 Participants
|
5 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=51 Participants
|
5 Participants
n=14 Participants
|
3 Participants
n=65 Participants
|
11 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=65 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=51 Participants
|
6 Participants
n=14 Participants
|
4 Participants
n=65 Participants
|
16 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7Treatment-emergent adverse events (TEAEs) were assessed starting after the first administration of investigational product until the final follow-up visit. A TEAE is defined as any AE that started or worsened in severity after the first dose of investigational product.
Outcome measures
| Measure |
Kindolor Cohort 1
n=6 Participants
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=6 Participants
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 Participants
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
6 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 48 hours post-doseArea under the plasma concentration-time (AUCt) curve from time 0 to the time (t) of last quantifiable concentration (Ct).
Outcome measures
| Measure |
Kindolor Cohort 1
n=6 Participants
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=6 Participants
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 Participants
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Pharmacokinetic AUCt of Kindolor Tosylate
|
3215.36 h*ng/mL
Standard Deviation 2826.83
|
2375.42 h*ng/mL
Standard Deviation 6326.00
|
NA h*ng/mL
Standard Deviation NA
All concentrations were below the limit of quantitation (BLQ); therefore, pharmacokinetic parameters could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 48 hours post-dosePopulation: One participant was excluded from analysis in kindolor cohorts 1 and 2 because results were non reportable.
Area under the plasma concentration-time curve (AUC∞) from time 0 extrapolated to infinity.
Outcome measures
| Measure |
Kindolor Cohort 1
n=5 Participants
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=5 Participants
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 Participants
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Pharmacokinetic AUC∞ of Kindolor Tosylate
|
3973.82 h*ng/mL
Standard Deviation 2754.99
|
2754.99 h*ng/mL
Standard Deviation 6764.42
|
NA h*ng/mL
Standard Deviation NA
All concentrations were below the limit of quantitation (BLQ); therefore, pharmacokinetic parameters could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 48 hours post-dosePopulation: One participant was excluded from analysis in kindolor cohorts 1 and 2 because results were non reportable.
The maximum observed plasma concentration.
Outcome measures
| Measure |
Kindolor Cohort 1
n=5 Participants
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=5 Participants
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 Participants
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Pharmacokinetic Cmax of Kindolor Tosylate
|
442.48 ng/mL
Standard Deviation 438.08
|
284.41 ng/mL
Standard Deviation 1386.85
|
NA ng/mL
Standard Deviation NA
All concentrations were below the limit of quantitation (BLQ); therefore, pharmacokinetic parameters could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 48 hours post-doseThe observed time to reach maximum plasma concentration.
Outcome measures
| Measure |
Kindolor Cohort 1
n=6 Participants
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=6 Participants
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 Participants
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Pharmacokinetic Tmax of Kindolor Tosylate
|
4 hr
Standard Deviation 3
|
5 hr
Standard Deviation 4
|
NA hr
Standard Deviation NA
All concentrations were below the limit of quantitation (BLQ); therefore, pharmacokinetic parameters could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 48 hours post-dosePopulation: One participant was excluded from analysis in kindolor cohorts 1 and 2 because results were non reportable.
The terminal-phase exponential rate constant.
Outcome measures
| Measure |
Kindolor Cohort 1
n=5 Participants
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=5 Participants
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 Participants
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Pharmacokinetic λz of Kindolor Tosylate
|
0.1255 1/hr
Standard Deviation 0.0416
|
0.0816 1/hr
Standard Deviation 0.0197
|
NA 1/hr
Standard Deviation NA
All concentrations were below the limit of quantitation (BLQ); therefore, pharmacokinetic parameters could not be calculated.
|
SECONDARY outcome
Timeframe: Up to 48 hours post-dosePopulation: One participant was excluded from analysis in kindolor cohorts 1 and 2 because results were non reportable.
The apparent terminal exponential half-life.
Outcome measures
| Measure |
Kindolor Cohort 1
n=5 Participants
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=5 Participants
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 Participants
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Pharmacokinetic t1/2 of Kindolor Tosylate
|
5.79 hr
Standard Deviation 2.25
|
8.70 hr
Standard Deviation 2.19
|
NA hr
Standard Deviation NA
All concentrations were below the limit of quantitation (BLQ); therefore, pharmacokinetic parameters could not be calculated.
|
Adverse Events
Kindolor Cohort 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Kindolor Cohort 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Comparator
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Kindolor Cohort 1
n=6 participants at risk
Kindolor Tosylate
1 tablet dose 100mg NPO for 8hrs x1 AM PO ex aq
|
Kindolor Cohort 2
n=6 participants at risk
Kindolor Tosylate tablet
1 tablet dose 300mg NPO for 8hrs x1 AM PO ex aq
|
Placebo Comparator
n=4 participants at risk
Placebo to Match tablet(s) NPO for 8hrs x1 AM PO ex aq
|
|---|---|---|---|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Gastrointestinal disorders
Faeces Pale
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
25.0%
1/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Infections and infestations
Pharyngitis
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Infections and infestations
Urinary tract infection
|
33.3%
2/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Crystal urine present
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
25.0%
1/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
25.0%
1/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
25.0%
1/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Nervous system disorders
Somnolence
|
33.3%
2/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
50.0%
2/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Cardiac disorders
Angina pectoris
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Ear and labyrinth disorders
Vision Blurred
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Creatinine renal clearance decreased
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Heart rate decreased
|
33.3%
2/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Specific gravity urine increased
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Protein urine present
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Prothrombin time prolonged
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Nervous system disorders
Brain Fog
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Nervous system disorders
Dizziness postural
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Renal and urinary disorders
Polyuria
|
33.3%
2/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
83.3%
5/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
50.0%
2/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/6 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
0.00%
0/4 • Starting after the administration of investigational product until the final follow-up visit (Day 7)
|
Additional Information
Director, Clinical Data Management
Fast-Track Drugs & Biologics, LLC
Phone: 2406727168
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place