rabeprazole has been researched along with Lung Neoplasms in 1 studies
Rabeprazole: A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
Lung Neoplasms: Tumors or cancer of the LUNG.
| Excerpt | Relevance | Reference |
|---|---|---|
| " The objectives of this phase 1, open-label crossover study (NCT02569554) in healthy adult participants were to determine (1) the effects of the proton pump inhibitor (PPI) rabeprazole on lorlatinib pharmacokinetics (PK), (2) the effects of a high-fat meal on lorlatinib PK, and (3) the relative bioavailability of an oral solution to tablet formulation of lorlatinib under fasted conditions." | 3.01 | Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants. ( Ginman, K; James, LP; Nepal, S; O'Gorman, MT; Pithavala, YK; Xu, H, 2021) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 0 (0.00) | 24.3611 |
| 2020's | 1 (100.00) | 2.80 |
| Authors | Studies |
|---|---|
| Xu, H | 1 |
| O'Gorman, MT | 1 |
| Nepal, S | 1 |
| James, LP | 1 |
| Ginman, K | 1 |
| Pithavala, YK | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 26-Week Multicenter Study to Evaluate the Efficacy and Safety of Ertugliflozin in Asian Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy (VERTIS-ASIA)[NCT02630706] | Phase 3 | 506 participants (Actual) | Interventional | 2015-12-16 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | Percentage A1C (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -1.00 |
| Ertugliflozin 15 mg | -0.89 |
| Placebo | -0.20 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Thus, this change from baseline reflects the Week 26 A1C minus the Week 0 A1C (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | Percentage A1C (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -1.01 |
| Ertugliflozin 15 mg | -0.92 |
| Placebo | -0.24 |
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -2.95 |
| Ertugliflozin 15 mg | -3.18 |
| Placebo | -1.17 |
The change in body weight from baseline reflects the Week 26 body weight minus the Week 0 body weight (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | Kilograms (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -3.11 |
| Ertugliflozin 15 mg | -3.38 |
| Placebo | -1.33 |
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -37.09 |
| Ertugliflozin 15 mg | -34.47 |
| Placebo | -6.69 |
Blood glucose was measured on a fasting basis. Blood was drawn at predose on Day 1 and after 26 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 26 minus FPG at Week 0) which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mg/dL (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -39.01 |
| Ertugliflozin 15 mg | -36.67 |
| Placebo | -10.46 |
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -2.38 |
| Ertugliflozin 15 mg | -2.36 |
| Placebo | -0.96 |
This change from baseline reflects the Week 26 sitting diastolic blood pressure (DBP) minus the Week 0 sitting DBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -2.82 |
| Ertugliflozin 15 mg | -2.77 |
| Placebo | -1.82 |
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -5.09 |
| Ertugliflozin 15 mg | -3.87 |
| Placebo | 0.22 |
This change from baseline reflects the Week 26 sitting systolic blood pressure (SBP) minus the Week 0 sitting SBP (which is estimated on average for each treatment group using a constrained longitudinal data analysis model, which allows for participants with missing data to be included in the analysis). Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Baseline and Week 26
| Intervention | mmHg (Least Squares Mean) |
|---|---|
| Ertugliflozin 5 mg | -5.64 |
| Ertugliflozin 15 mg | -4.19 |
| Placebo | -1.56 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 12: 60 min. Post-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 91.49 |
| Ertugliflozin 15 mg | 277.60 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 12: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 8.18 |
| Ertugliflozin 15 mg | 27.11 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 18: 60 min. Post-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 91.40 |
| Ertugliflozin 15 mg | 274.23 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 18: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 6.59 |
| Ertugliflozin 15 mg | 17.54 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 26: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 7.34 |
| Ertugliflozin 15 mg | 26.66 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 6: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 9.17 |
| Ertugliflozin 15 mg | 24.59 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 12: 60 min. Post-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 97.36 |
| Ertugliflozin 15 mg | 294.49 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 12: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 7.40 |
| Ertugliflozin 15 mg | 23.84 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 18: 60 min. Post-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 94.82 |
| Ertugliflozin 15 mg | 285.28 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 18: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 6.30 |
| Ertugliflozin 15 mg | 17.07 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 26: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 7.26 |
| Ertugliflozin 15 mg | 24.91 |
No ertugliflozin plasma concentrations were determined for participants receiving placebo. Lower limit of quantification for ertugliflozin was 0.500 ng/mL. (NCT02630706)
Timeframe: Week 6: Pre-Dose
| Intervention | ng/mL (Mean) |
|---|---|
| Ertugliflozin 5 mg | 7.88 |
| Ertugliflozin 15 mg | 22.29 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02630706)
Timeframe: Up to 26 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 1.2 |
| Ertugliflozin 15 mg | 0.6 |
| Placebo | 1.8 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02630706)
Timeframe: Up to 26 weeks
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 0.7 |
| Ertugliflozin 15 mg | 0.7 |
| Placebo | 2.2 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02630706)
Timeframe: Up to 28 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 56.5 |
| Ertugliflozin 15 mg | 53.3 |
| Placebo | 59.3 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT02630706)
Timeframe: Up to 28 weeks
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 54.4 |
| Ertugliflozin 15 mg | 50.4 |
| Placebo | 59.3 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 0.0 |
| Ertugliflozin 15 mg | 0.7 |
| Placebo | 9.6 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of Participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 1.2 |
| Ertugliflozin 15 mg | 0.6 |
| Placebo | 9.6 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 14.7 |
| Ertugliflozin 15 mg | 15.4 |
| Placebo | 2.4 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 14.7 |
| Ertugliflozin 15 mg | 17.0 |
| Placebo | 3.0 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 38.2 |
| Ertugliflozin 15 mg | 40.8 |
| Placebo | 16.2 |
A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. Per protocol, this data set excludes data for any participant after the initiation of glycemic rescue therapy. (NCT02630706)
Timeframe: Week 26
| Intervention | Percentage of participants (Number) |
|---|---|
| Ertugliflozin 5 mg | 35.3 |
| Ertugliflozin 15 mg | 42.2 |
| Placebo | 18.5 |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. (NCT02630706)
Timeframe: Up to 183 days
| Intervention | Days (Median) |
|---|---|
| Ertugliflozin 5 mg | NA |
| Ertugliflozin 15 mg | NA |
| Placebo | NA |
Per protocol, participants who met pre-specified glycemic criteria were rescued with oral tablets of open-label glimepiride and dosed according to Investigator judgment. (NCT02630706)
Timeframe: Up to 149 days
| Intervention | Days (Median) |
|---|---|
| Ertugliflozin 15 mg | NA |
| Placebo | NA |
1 trial available for rabeprazole and Lung Neoplasms
| Article | Year |
|---|---|
Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants.
Topics: Adult; Aminopyridines; Carcinoma, Non-Small-Cell Lung; Cross-Over Studies; Drug Interactions; Female | 2021 |