Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
Trial · NCT03291288
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 50
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam | Part 1: Midazolam Only | 13.6 | Standard Deviation 6.8 | ng/mL | |
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | 12.0 | Standard Deviation 4.9 | ng/mL | |
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) | 9.7 | Standard Deviation 4.1 | ng/mL | |
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Tolbutamide | Part 1: Tolbutamide Only | 44400 | Standard Deviation 13100 | ng/mL | |
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Tolbutamide | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 1) | 46700 | Standard Deviation 16300 | ng/mL | |
| Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Tolbutamide | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 11) | 44400 | Standard Deviation 12200 | ng/mL | |
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam | Part 1: Midazolam Only | 0.525 | Full Range 0.333 to 1.37 | hours | |
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | 0.5 | Full Range 0.417 to 1.42 | hours | |
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) | 0.5 | Full Range 0.333 to 0.917 | hours | |
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Tolbutamide | Part 1: Tolbutamide Only | 2.90 | Full Range 1 to 8.2 | hours | |
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Tolbutamide | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 1) | 2.94 | Full Range 1.52 to 8.08 | hours | |
| Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Tolbutamide | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 11) | 3.17 | Full Range 2.45 to 6.02 | hours | |
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam | Part 1: Midazolam Only | 43.7 | Standard Deviation 34.1 | ng*hour/mL | |
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 1) | 31.6 | Standard Deviation 19.6 | ng*hour/mL | |
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam | Part 1: Pexidartinib + Midazolam (Cycle 1, Day 11) | 18.5 | Standard Deviation 8.2 | ng*hour/mL | |
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Tolbutamide | Part 1: Tolbutamide Only | 500000 | Standard Deviation 196000 | ng*hour/mL | |
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Tolbutamide | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 1) | 585000 | Standard Deviation 234000 | ng*hour/mL | |
| Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Tolbutamide | Part 1: Pexidartinib + Tolbutamide (Cycle 1, Day 11) | 700000 | Standard Deviation 207000 | ng*hour/mL | |
| Overall Summary of Treatment-emergent Adverse Events | Part 1: Drug-drug Interaction Phase | TEAEs | 24 | Participants | |
| Overall Summary of Treatment-emergent Adverse Events | Part 2: Pexidartinib Only | TEAEs | 23 | Participants |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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