TriangleNCT02657889 · OUTCOME
Phase 1: Cmin,ss and Cmax,ss of Major Metabolite of Niraparib (M1)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Nanograms per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- Pre-dose and 1, 2, 4, 6, 8, 24 Hours post-dose on Cycle 2 Day 1(each cycle of 21 days)
What was measured
Blood samples were collected at indicated time points. Pharmacokinetic analysis of major metabolite of Niraparib (M1) was conducted using standard non-compartmental analysis.
Analysis population: Pharmacokinetic Analysis Set. Only those participants with data available at the specified time points were analyzed.
Groups in this outcome
Phase 1: Niraparib 200 mg + Pembrolizumab
Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
Phase 1: Niraparib 300 mg + Pembrolizumab
Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
| Group | Source count |
|---|---|
| Phase 1: Niraparib 200 mg + Pembrolizumab | 4 |
| Phase 1: Niraparib 300 mg + Pembrolizumab | 3 |
Reported measurements
Cmin,ss
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Niraparib 200 mg + Pembrolizumab | 1410.000 | 207.686 | Not reported | Not reported | Not reported |
| Phase 1: Niraparib 300 mg + Pembrolizumab | 3280.000 | 1460.411 | Not reported | Not reported | Not reported |
Cmax,ss
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Niraparib 200 mg + Pembrolizumab | 2177.50 | 475.000 | Not reported | Not reported | Not reported |
| Phase 1: Niraparib 300 mg + Pembrolizumab | 4213.33 | 1515.333 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 207.686
- value
- 1410.000
- group Id
- OG001
- spread
- 1460.411
- value
- 3280.000
- title
- Cmin,ss
- categories
- measurements
- group Id
- OG000
- spread
- 475.000
- value
- 2177.50
- group Id
- OG001
- spread
- 1515.333
- value
- 4213.33
- title
- Cmax,ss
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- description
- Blood samples were collected at indicated time points. Pharmacokinetic analysis of major metabolite of Niraparib (M1) was conducted using standard non-compartmental analysis.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
- id
- OG000
- title
- Phase 1: Niraparib 200 mg + Pembrolizumab
- description
- Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
- id
- OG001
- title
- Phase 1: Niraparib 300 mg + Pembrolizumab
- param Type
- MEAN
- population Description
- Pharmacokinetic Analysis Set. Only those participants with data available at the specified time points were analyzed.
- reporting Status
- POSTED
- time Frame
- Pre-dose and 1, 2, 4, 6, 8, 24 Hours post-dose on Cycle 2 Day 1(each cycle of 21 days)
- title
- Phase 1: Cmin,ss and Cmax,ss of Major Metabolite of Niraparib (M1)
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice