TriangleNCT04256707 · OUTCOME
Monotherapy: Apparent Clearance (CL/F) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- L/h
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8
What was measured
CL/F was defined as the apparent clearance of selinexor.
Analysis population: PK analysis was defined as all participants in the monotherapy part who received at least 1 dose of selinexor and had at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of selinexor (e.g., vomited at or before 6 hours; wrong dose administered; prohibited concomitant medication). Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Groups in this outcome
Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function
Participants with normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally QW on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function
Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally QW on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function
Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablet) orally QW on Day 1 until PD, intolerability, or Investigator decision.
Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function
Participants with severe hepatic function received Tablet A (selinexor 2 x 20 mg tablet) orally QW on Day 1 until PD, intolerability, or Investigator decision.
| Group | Source count |
|---|---|
| Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function | 19 |
| Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function | 19 |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function | 6 |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function | 14.5 | 28.7 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function | 14.3 | 27.1 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function | 17.6 | 16.3 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function | 9.86 | 24.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 28.7
- value
- 14.5
- group Id
- OG001
- spread
- 27.1
- value
- 14.3
- group Id
- OG002
- spread
- 16.3
- value
- 17.6
- group Id
- OG003
- spread
- 24.4
- value
- 9.86
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- CL/F was defined as the apparent clearance of selinexor.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally QW on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
- id
- OG000
- title
- Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function
- description
- Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally QW on Day 1 or Day 8, until PD, intolerability, or Investigator decision.
- id
- OG001
- title
- Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function
- description
- Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablet) orally QW on Day 1 until PD, intolerability, or Investigator decision.
- id
- OG002
- title
- Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function
- description
- Participants with severe hepatic function received Tablet A (selinexor 2 x 20 mg tablet) orally QW on Day 1 until PD, intolerability, or Investigator decision.
- id
- OG003
- title
- Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function
- param Type
- GEOMETRIC_MEAN
- population Description
- PK analysis was defined as all participants in the monotherapy part who received at least 1 dose of selinexor and had at least 1 post-dose PK measurement without important protocol deviations/violations or events thought to significantly affect the PK of selinexor (e.g., vomited at or before 6 hours; wrong dose administered; prohibited concomitant medication). Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 24, 30, and 48 hours post-dose on Days 1 and 8
- title
- Monotherapy: Apparent Clearance (CL/F) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment
- type
- SECONDARY
- unit Of Measure
- L/h
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Preserved source evidence · Not medical advice