TriangleNCT04256707 · OUTCOME
Monotherapy: Terminal Elimination Rate Constant (Lambda z) 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
- liter per hour (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
Lambda z was defined as the terminal elimination rate constant 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 | 0.101 | 19.3 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function | 0.106 | 28.6 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function | 0.124 | 29.8 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function | 0.128 | 50.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19.3
- value
- 0.101
- group Id
- OG001
- spread
- 28.6
- value
- 0.106
- group Id
- OG002
- spread
- 29.8
- value
- 0.124
- group Id
- OG003
- spread
- 50.3
- value
- 0.128
- 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
- Lambda z was defined as the terminal elimination rate constant 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: Terminal Elimination Rate Constant (Lambda z) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment
- type
- SECONDARY
- unit Of Measure
- liter per hour (l/h)
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Preserved source evidence · Not medical advice