TriangleNCT03037385 · OUTCOME
Phase 1: Terminal Elimination Half-Life (t½)
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
- Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days)
What was measured
The maximum values for t1/2 slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM.
Analysis population: PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Groups in this outcome
Phase I: Pralsetinib 30 mg
Participants received pralsetinib 30 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 60 mg
Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 100 mg
Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 200 mg
Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 300 mg
Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 400 mg
Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 600 mg
Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 100/100 mg
Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons.
Phase I: Pralsetinib 200/100 mg
Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons.
| Group | Source count |
|---|---|
| Phase I: Pralsetinib 30 mg | 2 |
| Phase I: Pralsetinib 60 mg | 5 |
| Phase I: Pralsetinib 100 mg | 3 |
| Phase I: Pralsetinib 200 mg | 10 |
| Phase I: Pralsetinib 300 mg | 5 |
| Phase I: Pralsetinib 400 mg | 7 |
| Phase I: Pralsetinib 600 mg | 3 |
| Phase I: Pralsetinib 100/100 mg | 0 |
| Phase I: Pralsetinib 200/100 mg | 1 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Phase I: Pralsetinib 30 mg | 2 |
| Phase I: Pralsetinib 60 mg | 5 |
| Phase I: Pralsetinib 100 mg | 3 |
| Phase I: Pralsetinib 200 mg | 10 |
| Phase I: Pralsetinib 300 mg | 5 |
| Phase I: Pralsetinib 400 mg | 7 |
| Phase I: Pralsetinib 600 mg | 3 |
| Phase I: Pralsetinib 100/100 mg | 0 |
| Phase I: Pralsetinib 200/100 mg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Pralsetinib 30 mg | 16.3 | Not reported | 11.8 | 20.8 | Not reported |
| Phase I: Pralsetinib 60 mg | 9.87 | Not reported | 8.98 | 18.3 | Not reported |
| Phase I: Pralsetinib 100 mg | 14.3 | Not reported | 8.12 | 31.5 | Not reported |
| Phase I: Pralsetinib 200 mg | 12.6 | Not reported | 6.69 | 34.9 | Not reported |
| Phase I: Pralsetinib 300 mg | 12.2 | Not reported | 9.53 | 34.5 | Not reported |
| Phase I: Pralsetinib 400 mg | 16.5 | Not reported | 10.2 | 48.7 | Not reported |
| Phase I: Pralsetinib 600 mg | 19.7 | Not reported | 12.8 | 36.1 | Not reported |
| Phase I: Pralsetinib 200/100 mg | 10.7 | Not reported | 10.7 | 10.7 | Not reported |
Cycle 1 Day 15
| Group | Source count |
|---|---|
| Phase I: Pralsetinib 30 mg | 1 |
| Phase I: Pralsetinib 60 mg | 4 |
| Phase I: Pralsetinib 100 mg | 3 |
| Phase I: Pralsetinib 200 mg | 9 |
| Phase I: Pralsetinib 300 mg | 5 |
| Phase I: Pralsetinib 400 mg | 5 |
| Phase I: Pralsetinib 600 mg | 1 |
| Phase I: Pralsetinib 100/100 mg | 0 |
| Phase I: Pralsetinib 200/100 mg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I: Pralsetinib 30 mg | 17.6 | Not reported | 17.6 | 17.6 | Not reported |
| Phase I: Pralsetinib 60 mg | 8.10 | Not reported | 5.25 | 39.6 | Not reported |
| Phase I: Pralsetinib 100 mg | 13.4 | Not reported | 12.5 | 14.4 | Not reported |
| Phase I: Pralsetinib 200 mg | 13.2 | Not reported | 10.1 | 21.8 | Not reported |
| Phase I: Pralsetinib 300 mg | 20.4 | Not reported | 9.91 | 27.3 | Not reported |
| Phase I: Pralsetinib 400 mg | 20.9 | Not reported | 9.21 | 33.6 | Not reported |
| Phase I: Pralsetinib 600 mg | 13.0 | Not reported | 13.0 | 13.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.8
- upper Limit
- 20.8
- value
- 16.3
- group Id
- OG001
- lower Limit
- 8.98
- upper Limit
- 18.3
- value
- 9.87
- group Id
- OG002
- lower Limit
- 8.12
- upper Limit
- 31.5
- value
- 14.3
- group Id
- OG003
- lower Limit
- 6.69
- upper Limit
- 34.9
- value
- 12.6
- group Id
- OG004
- lower Limit
- 9.53
- upper Limit
- 34.5
- value
- 12.2
- group Id
- OG005
- lower Limit
- 10.2
- upper Limit
- 48.7
- value
- 16.5
- group Id
- OG006
- lower Limit
- 12.8
- upper Limit
- 36.1
- value
- 19.7
- group Id
- OG008
- lower Limit
- 10.7
- upper Limit
- 10.7
- value
- 10.7
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.6
- upper Limit
- 17.6
- value
- 17.6
- group Id
- OG001
- lower Limit
- 5.25
- upper Limit
- 39.6
- value
- 8.10
- group Id
- OG002
- lower Limit
- 12.5
- upper Limit
- 14.4
- value
- 13.4
- group Id
- OG003
- lower Limit
- 10.1
- upper Limit
- 21.8
- value
- 13.2
- group Id
- OG004
- lower Limit
- 9.91
- upper Limit
- 27.3
- value
- 20.4
- group Id
- OG005
- lower Limit
- 9.21
- upper Limit
- 33.6
- value
- 20.9
- group Id
- OG006
- lower Limit
- 13.0
- upper Limit
- 13.0
- value
- 13.0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 15
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 7
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- units
- Participants
- description
- The maximum values for t1/2 slightly exceed 24 hours because the analysis used the actual time, i.e., the duration between dosing and actual sample collection, rather than the nominal sampling time of 24 hours specified in the protocol. The timeframe has been given as per nominal sampling timepoints pre-specified in the protocol. Number of participants in each arm of this OM is based on the actual treatment received. 1 participant originally assigned to the 200/100 mg arm received the 100/100 mg treatment and hence, was counted under the 100/100 mg arm for this OM.
- dispersion Type
- Full Range
- groups
- description
- Participants received pralsetinib 30 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG000
- title
- Phase I: Pralsetinib 30 mg
- description
- Participants received pralsetinib 60 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG001
- title
- Phase I: Pralsetinib 60 mg
- description
- Participants received pralsetinib 100 mg orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG002
- title
- Phase I: Pralsetinib 100 mg
- description
- Participants received pralsetinib 200 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG003
- title
- Phase I: Pralsetinib 200 mg
- description
- Participants received pralsetinib 300 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG004
- title
- Phase I: Pralsetinib 300 mg
- description
- Participants received pralsetinib 400 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG005
- title
- Phase I: Pralsetinib 400 mg
- description
- Participants received pralsetinib 600 mg, orally, QD until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG006
- title
- Phase I: Pralsetinib 600 mg
- description
- Participants received pralsetinib 100 mg, orally, BID until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG007
- title
- Phase I: Pralsetinib 100/100 mg
- description
- Participants received pralsetinib 200 mg in the morning and then 100 mg in the evening orally until discontinuation due to toxicity, disease progression, or other reasons.
- id
- OG008
- title
- Phase I: Pralsetinib 200/100 mg
- param Type
- MEDIAN
- population Description
- PK evaluable population included all participants who received at least one dose of pralsetinib and from whom at least one post dose PK sample was collected. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Predose on 0.5, 1, 2, 4, 6, 8 and 24 hours postdose on Days 1 and 15 of Cycle 1 (1 cycle = 28 days)
- title
- Phase 1: Terminal Elimination Half-Life (t½)
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice