TriangleNCT04256707 · OUTCOME
Monotherapy: Area Under the Concentration-Time Curve From Time Zero to Time of Last Concentration (AUC 0-t) 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
- hour*nanograms per milliliter (h*ng/mL)
- 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
AUC0-t was defined as the total-drug area under the concentration-time curve from time zero to time of last concentration measured.
Analysis population: Pharmacokinetics (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).
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 × 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 | 7 |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function | 6830 | 28.8 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function | 6920 | 27.2 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet): Moderate Hepatic Function | 2380 | 24.0 | Not reported | Not reported | Not reported |
| Monotherapy: Tablet A (Selinexor 2 x 20 mg Tablet) Severe Hepatic Function | 3860 | 22.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 28.8
- value
- 6830
- group Id
- OG001
- spread
- 27.2
- value
- 6920
- group Id
- OG002
- spread
- 24.0
- value
- 2380
- group Id
- OG003
- spread
- 22.4
- value
- 3860
- denoms
- counts
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 19
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- AUC0-t was defined as the total-drug area under the concentration-time curve from time zero to time of last concentration measured.
- 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 × 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
- Pharmacokinetics (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).
- 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: Area Under the Concentration-Time Curve From Time Zero to Time of Last Concentration (AUC 0-t) of Total Selinexor in Participants With Normal, Moderate and Severe Hepatic Impairment
- type
- PRIMARY
- unit Of Measure
- hour*nanograms per milliliter (h*ng/mL)
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Preserved source evidence · Not medical advice