TriangleNCT02365597 · OUTCOME
Drug-Drug Interaction (DDI) Substudy: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam 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
- MEDIAN
- Unit
- Hours
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 Day -2 (predose) up to Day 13 post dose (each cycle length=28 days)
What was measured
Tmax is the time to reach the maximum observed plasma concentration of 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: Midazolam 2.5 mg Alone
Participants received single dose of pretreatment 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: Midazolam 2.5 mg + Erdafitinib 8 mg
Participants received single dose of pretreatment 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: Midazolam 2.5 mg Alone | 23 |
| DDI Study: Midazolam 2.5 mg + Erdafitinib 8 mg | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| DDI Study: Midazolam 2.5 mg Alone | 0.50 | Not reported | 0.47 | 1.08 | Not reported |
| DDI Study: Midazolam 2.5 mg + Erdafitinib 8 mg | 0.58 | Not reported | 0.45 | 2.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.47
- upper Limit
- 1.08
- value
- 0.50
- group Id
- OG001
- lower Limit
- 0.45
- upper Limit
- 2.00
- value
- 0.58
- denoms
- counts
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- Tmax is the time to reach the maximum observed plasma concentration of midazolam alone or in combination with erdafitinib.
- dispersion Type
- Full Range
- groups
- description
- Participants received single dose of pretreatment 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: Midazolam 2.5 mg Alone
- description
- Participants received single dose of pretreatment 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: Midazolam 2.5 mg + Erdafitinib 8 mg
- param Type
- MEDIAN
- 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: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Midazolam Alone or in Combination With Erdafitinib
- type
- PRIMARY
- unit Of Measure
- Hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice