Effect of Pexidartinib on the Way the Body Processes CYP3A4 and CYP2C9 Substrates (Pharmacokinetics)
Trial · NCT03291288
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam | Baseline to 15 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Tolbutamide | Baseline to 15 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam | Baseline to 15 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | hours | MEDIAN |
| PRIMARY | Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Tolbutamide | Baseline to 15 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | hours | MEDIAN |
| PRIMARY | Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam | Baseline to 15 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | ng*hour/mL | MEAN |
| PRIMARY | Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Tolbutamide | Baseline to 15 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | ng*hour/mL | MEAN |
| PRIMARY | Overall Summary of Treatment-emergent Adverse Events | Baseline to 1 year post treatment | Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Pexidartinib and ZAAD-1006a Metabolite | Baseline to 13 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Pexidartinib and ZAAD-1006a Metabolite | Baseline to 13 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | hours | MEDIAN |
| SECONDARY | Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Pexidartinib and ZAAD-1006a Metabolite | Baseline to 13 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | ng*hour/mL | MEAN |
| SECONDARY | Pharmacokinetic Analysis: Maximum Concentration (Cmax) for Midazolam Metabolite, 1-Hydroxy Midazolam | Baseline to 13 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic Analysis: Time to Maximum Concentration (Tmax) for Midazolam Metabolite, 1-Hydroxy Midazolam | Baseline to 13 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | hours | MEDIAN |
| SECONDARY | Pharmacokinetic Analysis: Area Under the Curve to the Last Observable Concentration (AUClast) for Midazolam Metabolite, 1-Hydroxy Midazolam | Baseline to 13 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | ng*hour/mL | MEAN |
| SECONDARY | Pharmacokinetic Analysis: Metabolite to Parent Ratio (MPR) for Midazolam | Baseline to 13 days post treatment | Pharmacokinetic parameters were assessed in the Pharmacokinetic Evaluable population. | Ratio | MEAN |
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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