Cmax (Maximum Observed Plasma Concentration)
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Bexagliflozin | 95.9 | 33.6 |
| Bexagliflozin With Exenatide | 121.6 | 33.1 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Bexagliflozin Drug/Drug Interaction Study With Exenatide Injection
NCT0316741124 May 2017 to 29 Jun 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to examine the drug-drug interaction when given the study drug, bexagliflozin, with one of the most commonly prescribed glucagon-like peptide 1 receptor agonist (GLP-1 RA) exenatide. The study will also evaluate how safe the study drug is and how well the study drug is tolerated when administered with exenatide injection.
Experimental
Bexagliflozin alone
Active comparator
Bexagliflozin with exenatide injection
Outcomes the sponsor listed as primary.
Cmax (Maximum Observed Plasma Concentration)
Time frame · Up to 48 hrs
Whole venous blood samples of 3 mL was collected from peripheral vein at each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. Cmax was obtained directly from experimental observations.
Tmax (Time of Maximum Observed Plasma Concentration)
Time frame · Up to 48 hrs
Whole venous blood samples of 3 mL was collected from peripheral vein at each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. Tmax was obtained directly from experimental observations.
T1/2 (Apparent Terminal Elimination Half-life)
Time frame · Up to 48 hrs
Whole venous blood samples of 3 mL was collected from peripheral vein at each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. T1/2 was calculated as the natural log of 2 divided by the terminal phase rate constant.
AUC0-inf (Area Under the Plasma Concentration-time Curve From Time 0 to Infinity)
Time frame · Up to 48 hrs
Whole venous blood samples of 3 mL was collected from peripheral vein at each period at pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 h post-dose of bexagliflozin. A non-compartmental pharmacokinetic analysis was used to calculate the PK parameters. AUC0-inf was calculated using the linear trapezoidal rule, using actual elapsed time values. If the actual time of sample collection was not available, the nominal time was used for the purpose of parameter estimation.
Urinary Glucose Excretion (UGE)
Time frame · 0-48 hours
Post-dose urine was collected without preservative in four batches: 0 to 12 h, 12 to 24 h, 24 to 36 h, and 36 to 48 h collections. After collection, the total volume of each batch and collection time was recorded. UGE, including UGE(t1-t2) and total 0-24 h and 0-48 h UGE were calculated. UGE(t1-t2) was derived from urine volume (Vt1-t2) multiplied by glucose concentration divided by 100.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (ng/mL) | Spread |
|---|---|---|
| Bexagliflozin | 95.9 | 33.6 |
| Bexagliflozin With Exenatide | 121.6 | 33.1 |
| Group | Value (hours) |
|---|---|
| Bexagliflozin | 2.00 |
| Bexagliflozin With Exenatide | 5.00 |
| Group | Value (hours) | Spread |
|---|---|---|
| Bexagliflozin | 12.1 | 45.3 |
| Bexagliflozin With Exenatide | 8.8 | 31.5 |
| Group | Value (hr*ng/mL) | Spread |
|---|---|---|
| Bexagliflozin | 776.0 | 27.5 |
| Bexagliflozin With Exenatide | 1085.3 | 29.5 |
| Group | Value (g) | Spread |
|---|---|---|
| Bexagliflozin | 0.07 | 0.140 |
| Bexagliflozin With Exenatide | 0.05 | 0.100 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| BexagliflozinBexagliflozin: Bexagliflozin tablets, 20 mg, oral, one dose | 0 / 20 | 0 / 20 | 4 / 20 |
| Bexagliflozin With ExenatideBexagliflozin: Bexagliflozin tablets, 20 mg, oral, one dose Exenatide: Byetta® (Exenatide), 10 µg, subcutaneous injection, twice a day (bid), two doses | 0 / 20 | 0 / 20 | 10 / 20 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
No study cites this trial.
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated