TriangleNCT02657889 · OUTCOME
Phase 1: Minimum Observed Plasma Concentration at Steady State (Cmin,ss) and Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Niraparib
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 Niraparib 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 | 878.75 | 651.122 | Not reported | Not reported | Not reported |
| Phase 1: Niraparib 300 mg + Pembrolizumab | 849.00 | 194.841 | Not reported | Not reported | Not reported |
Cmax,ss
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Niraparib 200 mg + Pembrolizumab | 1585.5 | 812.63 | Not reported | Not reported | Not reported |
| Phase 1: Niraparib 300 mg + Pembrolizumab | 1606.7 | 261.02 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 651.122
- value
- 878.75
- group Id
- OG001
- spread
- 194.841
- value
- 849.00
- title
- Cmin,ss
- categories
- measurements
- group Id
- OG000
- spread
- 812.63
- value
- 1585.5
- group Id
- OG001
- spread
- 261.02
- value
- 1606.7
- 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 Niraparib 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: Minimum Observed Plasma Concentration at Steady State (Cmin,ss) and Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Niraparib
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice