TriangleNCT02365597 · OUTCOME
Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
What was measured
AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of 1-OH-Midazolam alone or in combination with erdafitinib.
Analysis population: Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
Groups in this outcome
DDI Study: 1-OH-Midazolam 2.5 mg Alone
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg
Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
| Group | Source count |
|---|---|
| DDI Study: 1-OH-Midazolam 2.5 mg Alone | 23 |
| DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DDI Study: 1-OH-Midazolam 2.5 mg Alone | 15.8 | 9.59 | Not reported | Not reported | Not reported |
| DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg | 15.1 | 10.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 9.59
- value
- 15.8
- group Id
- OG001
- spread
- 10.4
- value
- 15.1
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- AUC(0-last) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration of 1-OH-Midazolam alone or in combination with erdafitinib.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 (each cycle length=28 days).
- id
- OG000
- title
- DDI Study: 1-OH-Midazolam 2.5 mg Alone
- description
- Participants received single dose of pretreatment 1-OH-Midazolam 2.5 mg syrup, orally, once daily, starting from Day -2 through Day 13 of Cycle 1 along with erdafitinib 8 mg starting from Day 1 up to Day 15 of Cycle 1 (each cycle length=28 days).
- id
- OG001
- title
- DDI Study: 1-OH-Midazolam 2.5 mg + Erdafitinib 8 mg
- param Type
- MEAN
- population Description
- Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 sample collected during treatment to determine the drug concentration. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
- title
- Drug-Drug Interaction (DDI) Substudy: Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUC[0-last]) of 1-OH-Midazolam (Midazolam Metabolite) Alone or in Combination With Erdafitinib
- type
- PRIMARY
- unit Of Measure
- ng*h/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice