Trial · NCT03296800
Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
NCT03296800, Phase 1, Completed, Theracos; results first posted 2021-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects. Trials, record NCT03296800. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03296800
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects
- NCT number
- NCT03296800
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 48 participants, actual
- Lead sponsor
- Theracos
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Bexagliflozin, Probenecid, Rifampin, Verapamil
- First posted
- 2017-09-28
- Last updated
- 2021-07-01
- Results first posted
- 2021-04-27
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax (Maximum Observed Plasma Concentration) | Up to 48 hours | Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA). |
| Primary | Tmax (Time of Maximum Observed Plasma Concentration) | Up to 48 hours | Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA). |
| Primary | T1/2 (Apparent Terminal Elimination Half-life) | Up to 48 hours | Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA). |
| Primary | AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) | Up to 48 hours | Whole venous blood samples of 3 mL were collected from a peripheral vein prior to dosing and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, and 48 h after administration of bexagliflozin; On Day 1 and Day 5 for Study 1, Day 1 and Day 6 for Study 2, Day 1 and Day 4 for Study 3. The pharmacokinetic parameters were estimated from the bexagliflozin plasma concentration data for each subject by non-compartmental analysis (NCA). |
| Secondary | Urinary Glucose Excretion 0-48 hr | 0 to 48 hours | Pre-dose urine samples were collected from -12 to 0 h for baseline measurement of pharmacodynamic parameters. Post-dose urine samples were collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36h, and 36 to 48 h after dosing. Urine aliquots were prepared from well mixed collections for the assessment of pharmacodynamics. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax (Maximum Observed Plasma Concentration) | Up to 48 hours | ng/mL | GEOMETRIC_MEAN | |
| PRIMARY | Tmax (Time of Maximum Observed Plasma Concentration) | Up to 48 hours | hours | MEDIAN | |
| PRIMARY | T1/2 (Apparent Terminal Elimination Half-life) | Up to 48 hours | hours | GEOMETRIC_MEAN | |
| PRIMARY | AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity) | Up to 48 hours | AUC0-t (from time 0 to time T) was used instead of AUC0-inf for Study 2 since AUC0-inf was not reported | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Urinary Glucose Excretion 0-48 hr | 0 to 48 hours | Only subjects with data in the specific category is included | g | MEAN |
Source ClinicalTrials.gov
Results by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax (Maximum Observed Plasma Concentration) | Study 1: Bexagliflozin Alone | 161.675 | Geometric Coefficient of Variation 28.673 | ng/mL | |
| Cmax (Maximum Observed Plasma Concentration) | Study 1: Bexagliflozin and Probenecid | 193.366 | Geometric Coefficient of Variation 22.098 | ng/mL | |
| Cmax (Maximum Observed Plasma Concentration) | Study 2: Bexagliflozin Alone | 97.811 | Geometric Coefficient of Variation 53.903 | ng/mL | |
| Cmax (Maximum Observed Plasma Concentration) | Study 2: Bexagliflozin and Rifampin | 117.001 | Geometric Coefficient of Variation 60.097 | ng/mL | |
| Cmax (Maximum Observed Plasma Concentration) | Study 3: Bexagliflozin Alone | 159.355 | Geometric Coefficient of Variation 35.396 | ng/mL | |
| Cmax (Maximum Observed Plasma Concentration) | Study 3: Bexagliflozin and Verapamil | 169.000 | Geometric Coefficient of Variation 24.727 | ng/mL | |
| Tmax (Time of Maximum Observed Plasma Concentration) | Bexagliflozin/Probenecid | Bexagliflozin alone | 2.000 | Full Range 2.000 to 4.000 | hours |
| Tmax (Time of Maximum Observed Plasma Concentration) | Bexagliflozin/Rifampin | Bexagliflozin alone | 2.000 | Full Range 2.000 to 4.083 | hours |
| Tmax (Time of Maximum Observed Plasma Concentration) | Bexagliflozin/Verapamil | Bexagliflozin alone | 3.0 | Full Range 2.000 to 8.000 | hours |
| Tmax (Time of Maximum Observed Plasma Concentration) | Bexagliflozin/Probenecid | Bexagliflozin + additional drug | 3.000 | Full Range 2.000 to 4.017 | hours |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid | 16 | |
| Overall Study | STARTED | Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin | 16 | |
| Overall Study | STARTED | Bexagliflozin, Then Verapamil and Bexagliflozin | 16 | |
| Overall Study | COMPLETED | Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid | 16 | |
| Overall Study | COMPLETED | Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin | 16 | |
| Overall Study | COMPLETED | Bexagliflozin, Then Verapamil and Bexagliflozin | 16 | |
| Overall Study | NOT COMPLETED | Bexagliflozin, Then Probenecid, Then Bexagliflozin and Probenecid | 0 | |
| Overall Study | NOT COMPLETED | Bexagliflozin, Then Rifampin, Then Bexagliflozin and Refampin | 0 | |
| Overall Study | NOT COMPLETED | Bexagliflozin, Then Verapamil and Bexagliflozin | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Study 1: Bexagliflozin Alone | 0 | 16 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Study 1: Bexagliflozin and Probenecid | 1 | 16 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Study 2: Bexagliflozin Alone | 0 | 16 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Study 2: Bexagliflozin and Rrifampin | 0 | 16 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Study 3: Bexagliflozin Alone | 0 | 16 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Study 3: Bexagliflozin and Verapamil | 0 | 16 | 0 |
| other | Gastrointestinal sounds abnormal | Gastrointestinal disorders | Study 1: Bexagliflozin Alone | 0 | 16 | 0 |
| other | Gastrointestinal sounds abnormal | Gastrointestinal disorders | Study 1: Bexagliflozin and Probenecid | 1 | 16 | 1 |
| other | Gastrointestinal sounds abnormal | Gastrointestinal disorders | Study 2: Bexagliflozin Alone | 0 | 16 | 0 |
| other | Gastrointestinal sounds abnormal | Gastrointestinal disorders | Study 2: Bexagliflozin and Rrifampin | 0 | 16 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study 1: Bexagliflozin Alone | 0 | 16 |
| Total, all-cause mortality | Study 1: Bexagliflozin and Probenecid | 0 | 16 |
| Total, all-cause mortality | Study 2: Bexagliflozin Alone | 0 | 16 |
| Total, all-cause mortality | Study 2: Bexagliflozin and Rrifampin | 0 | 16 |
| Total, all-cause mortality | Study 3: Bexagliflozin Alone | 0 | 16 |
| Total, all-cause mortality | Study 3: Bexagliflozin and Verapamil | 0 | 16 |
| Total, other adverse events | Study 1: Bexagliflozin Alone | 0 | 16 |
| Total, other adverse events | Study 1: Bexagliflozin and Probenecid | 1 | 16 |
| Total, other adverse events | Study 2: Bexagliflozin Alone | 0 | 16 |
| Total, other adverse events | Study 2: Bexagliflozin and Rrifampin | 0 | 16 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03296800
GET https://conductscience.org/api/trials/v1/NCT03296800/results?page=2