Trial Outcomes & Findings for A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants (NCT NCT05436912)
NCT ID: NCT05436912
Last Updated: 2025-04-13
Results Overview
PK: Cmax of selpercatinib was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdose
Results posted on
2025-04-13
Participant Flow
Participant milestones
| Measure |
160 Milligram (mg) Selpercatinib: Normal Hepatic Function
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
8
|
8
|
8
|
|
Overall Study
Received at Least One Dose of Study Drug
|
12
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
12
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Effects of Selpercatinib in Hepatically Impaired Participants and Healthy Participants
Baseline characteristics by cohort
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per CP classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
59 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
57 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
53 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
56 years
STANDARD_DEVIATION 6.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Cmax of selpercatinib was reported.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Selpercatinib
|
898 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 129.8
|
1170 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 78.0
|
732 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 185.6
|
952 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 72.3
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Tmax of Selpercatinib was reported.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: Time to Reach Cmax (Tmax) of Selpercatinib
|
2.00 hour
Interval 1.0 to 24.0
|
1.53 hour
Interval 1.0 to 2.03
|
2.00 hour
Interval 1.0 to 24.42
|
1.50 hour
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC0-t was calculated using the linear trapezoidal rule for increasing and decreasing concentrations.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration-time Curve (AUC), From Time 0 to the Last Observed Non-zero Concentration (AUC0-t) of Selpercatinib
|
17700 hour*nanogram per milliliter (h*ng/ mL)
Geometric Coefficient of Variation 65.0
|
20200 hour*nanogram per milliliter (h*ng/ mL)
Geometric Coefficient of Variation 43.1
|
14600 hour*nanogram per milliliter (h*ng/ mL)
Geometric Coefficient of Variation 74.0
|
27100 hour*nanogram per milliliter (h*ng/ mL)
Geometric Coefficient of Variation 33.7
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Area under the plasma concentration time curve extrapolated to infinity, calculated as AUC(0-t) + Ct/λZ, where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: AUC Extrapolated to Infinity (AUC0-∞) of Selpercatinib
|
17700 hour*nanogram per milliliter (h*ng/ mL)
Geometric Coefficient of Variation 64.9
|
20200 hour*nanogram per milliliter (h*ng/ mL)
Geometric Coefficient of Variation 43.0
|
14700 hour*nanogram per milliliter (h*ng/ mL)
Geometric Coefficient of Variation 73.6
|
27300 hour*nanogram per milliliter (h*ng/ mL)
Geometric Coefficient of Variation 33.5
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: %AUCextrap of Selpercatinib was reported.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: Percentage Extrapolation for AUC (%AUCextrap) of Selpercatinib
|
0.422 percentage of (%) of AUCextrap
Standard Deviation 0.190
|
0.310 percentage of (%) of AUCextrap
Standard Deviation 0.197
|
0.373 percentage of (%) of AUCextrap
Standard Deviation 0.328
|
0.685 percentage of (%) of AUCextrap
Standard Deviation 0.379
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Apparent terminal elimination rate constant, where λZ is the magnitude of the slope of the linear regression of the log concentration versus-time profile during the terminal phase.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: Apparent Terminal Elimination Rate Constant (λz) of Selpercatinib
|
0.0220 1/hour (1/h)
Geometric Coefficient of Variation 61.4
|
0.0266 1/hour (1/h)
Geometric Coefficient of Variation 39.8
|
0.0320 1/hour (1/h)
Geometric Coefficient of Variation 29.0
|
0.0175 1/hour (1/h)
Geometric Coefficient of Variation 28.8
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Apparent terminal elimination half-life (whenever possible), where t1/2 = natural log (ln)(2)/λZ.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: Apparent Terminal Elimination Half-life (t1/2) of Selpercatinib
|
36.4 hour
Standard Deviation 19.9
|
27.9 hour
Standard Deviation 12.2
|
22.4 hour
Standard Deviation 6.30
|
41.3 hour
Standard Deviation 13.5
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC (0-inf), expressed in liter/hour (L/hr).
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: Apparent Systemic Clearance (CL/F) of Selpercatinib
|
9.03 Liters per Hour (L/h)
Geometric Coefficient of Variation 64.9
|
7.90 Liters per Hour (L/h)
Geometric Coefficient of Variation 43.0
|
10.9 Liters per Hour (L/h)
Geometric Coefficient of Variation 73.6
|
5.87 Liters per Hour (L/h)
Geometric Coefficient of Variation 33.5
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Vd/F was calculated as CL/F/λZ.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: Apparent Volume of Distribution During the Terminal Phase (Vd/F) of Selpercatinib
|
411 Liter (L)
Geometric Coefficient of Variation 51.5
|
297 Liter (L)
Geometric Coefficient of Variation 58.0
|
340 Liter (L)
Geometric Coefficient of Variation 68.6
|
336 Liter (L)
Geometric Coefficient of Variation 51.8
|
PRIMARY outcome
Timeframe: Predose (within 30 minutes), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, and 240 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: MRT represents the average time the drug (selpercatinib) stays in the body.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
PK: Mean Residence Time (MRT) of Selpercatinib
|
25.5 hour
Geometric Coefficient of Variation 21.9
|
23.3 hour
Geometric Coefficient of Variation 28.9
|
24.2 hour
Geometric Coefficient of Variation 39.2
|
34.3 hour
Geometric Coefficient of Variation 20.2
|
PRIMARY outcome
Timeframe: Baseline up to Week 7Population: All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 Participants
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with mild hepatic impairment per Child-Pugh \[CP\] classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 Participants
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 Participants
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
160 mg Selpercatinib: Normal Hepatic Function
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
160 mg Selpercatinib: Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
160 mg Selpercatinib: Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
160 mg Selpercatinib: Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
160 mg Selpercatinib: Normal Hepatic Function
n=12 participants at risk
160 mg selpercatinib administered orally to healthy participants after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Mild Hepatic Impairment
n=8 participants at risk
160 mg selpercatinib administered orally to participants with mild hepatic impairment per CP classification (CP Class A, score of 5 or 6) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Moderate Hepatic Impairment
n=8 participants at risk
160 mg selpercatinib administered orally to participants with moderate hepatic impairment per CP classification (CP Class B, score of 7 to 9) after at least a 2-hour fast on Day 1.
|
160 mg Selpercatinib: Severe Hepatic Impairment
n=8 participants at risk
160 mg Selpercatinib administered orally to participants with severe hepatic impairment per CP classification (CP Class C, score of 10 to 15) after at least a 2-hour fast on Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
8.3%
1/12 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/12 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
12.5%
1/8 • Number of events 1 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
0.00%
0/8 • Baseline up to Week 7
All randomized participants who received at least one dose of study drug and had at least one post dose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60