TriangleNCT04209465 · OUTCOME
Phase 1: Plasma Concentration of BDTX-189 as a Measure of Pharmacokinetics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Nanogram per mililiter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Multiple time points during Cycles 1-4 (each cycle is 21 days)
What was measured
Blood samples will be taken to measure the plasma concentrations of BDTX-189 in both a fed and fasted state.
Groups in this outcome
Dose Escalation 25 mg QD
Patients who received doses at 25 mg once daily under fasted conditions.
Dose Escalation 50 mg QD
Patients who received doses at 50 mg once daily under fasted conditions.
Dose Escalation 100 mg QD
Patients who received doses at 100 mg once daily under fasted conditions.
Dose Escalation 200 mg QD
Patients who received doses at 200 mg once daily under fasted conditions.
Dose Escalation 400 mg QD
Patients who received 400 mg once daily under fasted conditions.
Dose Escalation 800 mg QD
Patients who received 800 mg once daily under fasted conditions.
Dose Escalation 800 mg QD NF
Patients who received 800 mg once daily under not fasted conditions.
Dose Escalation 1000 mg QD
Patients who received 1000 mg once daily under not fasted conditions
Dose Escalation 1200 mg QD
Patients who received 1200 mg once daily under fasted conditions.
Dose Escalation 400 mg BID
Patients who received 400 mg twice daily under not fasted conditions.
Dose Escalation 600 mg BID
Patients who received 600 mg twice daily under not fasted conditions.
Dose Escalation 800 mg BID
Patients who received 800 mg twice daily under fasted conditions.
Safety Expansion 800 mg QD
Patients in safety expansion who received 800 mg once daily under not fasted conditions.
| Group | Source count |
|---|---|
| Dose Escalation 25 mg QD | 1 |
| Dose Escalation 50 mg QD | 1 |
| Dose Escalation 100 mg QD | 1 |
| Dose Escalation 200 mg QD | 2 |
| Dose Escalation 400 mg QD | 9 |
| Dose Escalation 800 mg QD | 13 |
| Dose Escalation 800 mg QD NF | 11 |
| Dose Escalation 1000 mg QD | 1 |
| Dose Escalation 1200 mg QD | 3 |
| Dose Escalation 400 mg BID | 3 |
| Dose Escalation 600 mg BID | 2 |
| Dose Escalation 800 mg BID | 3 |
| Safety Expansion 800 mg QD | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation 25 mg QD | NA | NA | Not reported | Not reported | Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant. |
| Dose Escalation 50 mg QD | NA | NA | Not reported | Not reported | Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant. |
| Dose Escalation 100 mg QD | NA | NA | Not reported | Not reported | Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant. |
| Dose Escalation 200 mg QD | 151 | 67.5 | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg QD | 170 | 104 | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD | 268 | 72.7 | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg QD NF | 341 | 46.4 | Not reported | Not reported | Not reported |
| Dose Escalation 1000 mg QD | 0 | 0 | Not reported | Not reported | Not reported |
| Dose Escalation 1200 mg QD | 352 | 77.8 | Not reported | Not reported | Not reported |
| Dose Escalation 400 mg BID | 123 | 133 | Not reported | Not reported | Not reported |
| Dose Escalation 600 mg BID | 84.5 | 39 | Not reported | Not reported | Not reported |
| Dose Escalation 800 mg BID | 165 | 53.8 | Not reported | Not reported | Not reported |
| Safety Expansion 800 mg QD | 248 | 77.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Geometric Mean (Geometric Coefficient of Variation) is not calculable for a single participant.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 67.5
- value
- 151
- group Id
- OG004
- spread
- 104
- value
- 170
- group Id
- OG005
- spread
- 72.7
- value
- 268
- group Id
- OG006
- spread
- 46.4
- value
- 341
- group Id
- OG007
- spread
- 0
- value
- 0
- group Id
- OG008
- spread
- 77.8
- value
- 352
- group Id
- OG009
- spread
- 133
- value
- 123
- group Id
- OG010
- spread
- 39
- value
- 84.5
- group Id
- OG011
- spread
- 53.8
- value
- 165
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 13
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 3
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 3
- units
- Participants
- description
- Blood samples will be taken to measure the plasma concentrations of BDTX-189 in both a fed and fasted state.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Patients who received doses at 25 mg once daily under fasted conditions.
- id
- OG000
- title
- Dose Escalation 25 mg QD
- description
- Patients who received doses at 50 mg once daily under fasted conditions.
- id
- OG001
- title
- Dose Escalation 50 mg QD
- description
- Patients who received doses at 100 mg once daily under fasted conditions.
- id
- OG002
- title
- Dose Escalation 100 mg QD
- description
- Patients who received doses at 200 mg once daily under fasted conditions.
- id
- OG003
- title
- Dose Escalation 200 mg QD
- description
- Patients who received 400 mg once daily under fasted conditions.
- id
- OG004
- title
- Dose Escalation 400 mg QD
- description
- Patients who received 800 mg once daily under fasted conditions.
- id
- OG005
- title
- Dose Escalation 800 mg QD
- description
- Patients who received 800 mg once daily under not fasted conditions.
- id
- OG006
- title
- Dose Escalation 800 mg QD NF
- description
- Patients who received 1000 mg once daily under not fasted conditions
- id
- OG007
- title
- Dose Escalation 1000 mg QD
- description
- Patients who received 1200 mg once daily under fasted conditions.
- id
- OG008
- title
- Dose Escalation 1200 mg QD
- description
- Patients who received 400 mg twice daily under not fasted conditions.
- id
- OG009
- title
- Dose Escalation 400 mg BID
- description
- Patients who received 600 mg twice daily under not fasted conditions.
- id
- OG010
- title
- Dose Escalation 600 mg BID
- description
- Patients who received 800 mg twice daily under fasted conditions.
- id
- OG011
- title
- Dose Escalation 800 mg BID
- param Type
- GEOMETRIC_MEAN
- reporting Status
- POSTED
- time Frame
- Multiple time points during Cycles 1-4 (each cycle is 21 days)
- title
- Phase 1: Plasma Concentration of BDTX-189 as a Measure of Pharmacokinetics
- type
- SECONDARY
- unit Of Measure
- Nanogram per mililiter (ng/mL)
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Preserved source evidence · Not medical advice