TriangleNCT02711345 · OUTCOME
Accumulation Ratio (Racc) of LTT462
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Ratio
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
What was measured
Racc is the accumulation ratio calculated by AUCtau ratio Day 15 versus Day 1.
Analysis population: PAS included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn't vomit within 4 hours postdose, had at least 1 primary PK parameter. Here 'N' number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
Groups in this outcome
LTT462 45 mg QD
Participants received 45 mg LTT462 QD as oral capsules.
LTT462 100 mg QD
Participants received 100 mg LTT462 QD as oral capsules.
LTT462 150 mg QD
Participants received 150 mg LTT462 QD as oral capsules.
LTT462 200 mg QD
Participants received 200 mg LTT462 QD as oral capsules.
LTT462 300 mg QD
Participants received 300 mg LTT462 QD as oral capsules.
LTT462 400 mg QD
Participants received 400 mg LTT462 QD as oral capsules.
LTT462 450 mg QD
Participants received 450 mg LTT462 QD as oral capsules.
LTT462 600 mg QD
Participants received 600 mg LTT462 QD as oral capsules.
LTT462 150 mg BID
Participants received 150 mg LTT462 twice daily (BID) as oral capsules.
LTT462 200 mg BID
Participants received 200 mg LTT462 BID as oral capsules.
| Group | Source count |
|---|---|
| LTT462 45 mg QD | 1 |
| LTT462 100 mg QD | 1 |
| LTT462 150 mg QD | 4 |
| LTT462 200 mg QD | 3 |
| LTT462 300 mg QD | 4 |
| LTT462 400 mg QD | 4 |
| LTT462 450 mg QD | 3 |
| LTT462 600 mg QD | 0 |
| LTT462 150 mg BID | 4 |
| LTT462 200 mg BID | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| LTT462 45 mg QD | 3.01 | NA | Not reported | Not reported | Geometric coefficient of variation was not calculated due to single participant in the arm. |
| LTT462 100 mg QD | 3.35 | NA | Not reported | Not reported | Geometric coefficient of variation was not calculated due to single participant in the arm. |
| LTT462 150 mg QD | 5.09 | 72.7 | Not reported | Not reported | Not reported |
| LTT462 200 mg QD | 2.74 | 46.9 | Not reported | Not reported | Not reported |
| LTT462 300 mg QD | 1.49 | 25.1 | Not reported | Not reported | Not reported |
| LTT462 400 mg QD | 1.73 | 62.4 | Not reported | Not reported | Not reported |
| LTT462 450 mg QD | 1.44 | 73.4 | Not reported | Not reported | Not reported |
| LTT462 150 mg BID | 3.19 | 50.2 | Not reported | Not reported | Not reported |
| LTT462 200 mg BID | 6.89 | 84.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric coefficient of variation was not calculated due to single participant in the arm.
- group Id
- OG000
- spread
- NA
- value
- 3.01
- comment
- Geometric coefficient of variation was not calculated due to single participant in the arm.
- group Id
- OG001
- spread
- NA
- value
- 3.35
- group Id
- OG002
- spread
- 72.7
- value
- 5.09
- group Id
- OG003
- spread
- 46.9
- value
- 2.74
- group Id
- OG004
- spread
- 25.1
- value
- 1.49
- group Id
- OG005
- spread
- 62.4
- value
- 1.73
- group Id
- OG006
- spread
- 73.4
- value
- 1.44
- group Id
- OG008
- spread
- 50.2
- value
- 3.19
- group Id
- OG009
- spread
- 84.3
- value
- 6.89
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- units
- Participants
- description
- Racc is the accumulation ratio calculated by AUCtau ratio Day 15 versus Day 1.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received 45 mg LTT462 QD as oral capsules.
- id
- OG000
- title
- LTT462 45 mg QD
- description
- Participants received 100 mg LTT462 QD as oral capsules.
- id
- OG001
- title
- LTT462 100 mg QD
- description
- Participants received 150 mg LTT462 QD as oral capsules.
- id
- OG002
- title
- LTT462 150 mg QD
- description
- Participants received 200 mg LTT462 QD as oral capsules.
- id
- OG003
- title
- LTT462 200 mg QD
- description
- Participants received 300 mg LTT462 QD as oral capsules.
- id
- OG004
- title
- LTT462 300 mg QD
- description
- Participants received 400 mg LTT462 QD as oral capsules.
- id
- OG005
- title
- LTT462 400 mg QD
- description
- Participants received 450 mg LTT462 QD as oral capsules.
- id
- OG006
- title
- LTT462 450 mg QD
- description
- Participants received 600 mg LTT462 QD as oral capsules.
- id
- OG007
- title
- LTT462 600 mg QD
- description
- Participants received 150 mg LTT462 twice daily (BID) as oral capsules.
- id
- OG008
- title
- LTT462 150 mg BID
- description
- Participants received 200 mg LTT462 BID as oral capsules.
- id
- OG009
- title
- LTT462 200 mg BID
- param Type
- GEOMETRIC_MEAN
- population Description
- PAS included of all participants who have at least 1 PK blood sample providing measurable LTT462 and received at least 1 dose of study drug, didn't vomit within 4 hours postdose, had at least 1 primary PK parameter. Here 'N' number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Days 1, 2, 3, 8, 15 and 16; Cycle 2 day 1 and 15; Cycle 3 Day 1; Cycle 5 Day 1
- title
- Accumulation Ratio (Racc) of LTT462
- type
- SECONDARY
- unit Of Measure
- Ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice