Trial Outcomes & Findings for A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Digoxin (P-Glycoprotein Substrate) in Healthy Participants (NCT NCT06194214)
NCT ID: NCT06194214
Last Updated: 2025-02-21
Results Overview
PK: AUC\[0-t\] of Digoxin was reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdose
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
Digoxin + Pirtobrutinib
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Digoxin + Pirtobrutinib
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LOXO-305) and Digoxin (P-Glycoprotein Substrate) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 8.25 • n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: AUC\[0-t\] of Digoxin was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of Digoxin in Plasma
Day 7
|
14.6 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 21.1
|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of Digoxin in Plasma
Day 8
|
17.1 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 19.6
|
|
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of Digoxin in Plasma
Day 16
|
48.9 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 22.0
|
PRIMARY outcome
Timeframe: Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: AUC \[tau\] of Digoxin was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Area Under the Concentration During a Dosing Interval (AUC [Tau]) of Digoxin in Plasma
Day 7
|
14.7 h*ng/mL
Geometric Coefficient of Variation 21.1
|
|
PK: Area Under the Concentration During a Dosing Interval (AUC [Tau]) of Digoxin in Plasma
Day 8
|
17.2 h*ng/mL
Geometric Coefficient of Variation 19.6
|
|
PK: Area Under the Concentration During a Dosing Interval (AUC [Tau]) of Digoxin in Plasma
Day 16
|
20.4 h*ng/mL
Geometric Coefficient of Variation 23.4
|
PRIMARY outcome
Timeframe: Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: CL/F of Digoxin in plasma was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Apparent Systemic Clearance (CL/F) of Digoxin in Plasma
Day 7
|
17.0 liter per hour(L/h)
Geometric Coefficient of Variation 21.1
|
|
PK: Apparent Systemic Clearance (CL/F) of Digoxin in Plasma
Day 8
|
14.5 liter per hour(L/h)
Geometric Coefficient of Variation 19.6
|
|
PK: Apparent Systemic Clearance (CL/F) of Digoxin in Plasma
Day 16
|
12.2 liter per hour(L/h)
Geometric Coefficient of Variation 23.4
|
PRIMARY outcome
Timeframe: Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: Cmax of Digoxin was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Maximum Observed Plasma Concentration (Cmax) of Digoxin in Plasma
Day 7
|
1.57 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26.1
|
|
PK: Maximum Observed Plasma Concentration (Cmax) of Digoxin in Plasma
Day 8
|
2.38 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 27.7
|
|
PK: Maximum Observed Plasma Concentration (Cmax) of Digoxin in Plasma
Day 16
|
2.45 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42.0
|
PRIMARY outcome
Timeframe: Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: Tmax of Digoxin was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Digoxin in Plasma
Day 7
|
1.27 hour
Interval 0.75 to 3.0
|
|
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Digoxin in Plasma
Day 8
|
1.25 hour
Interval 0.75 to 3.0
|
|
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Digoxin in Plasma
Day 16
|
1.00 hour
Interval 0.75 to 2.5
|
PRIMARY outcome
Timeframe: Day 7 and Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: MRT of Digoxin was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Mean Residence Time (MRT) of Digoxin in Plasma
Day 7
|
52.2 hours
Geometric Coefficient of Variation 49.1
|
|
PK: Mean Residence Time (MRT) of Digoxin in Plasma
Day 8
|
65.2 hours
Geometric Coefficient of Variation 47.2
|
|
PK: Mean Residence Time (MRT) of Digoxin in Plasma
Day 16
|
60.4 hours
Geometric Coefficient of Variation 52.5
|
PRIMARY outcome
Timeframe: Day 7 and Day 16: Predose, 6, 12, 24 hours post dosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: Ae of Digoxin in urine was reported. The urine sampling time points from pre-dose through 24 hours post-dose were used to assess this outcome.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Cumulative Amount of Drug Excreted Unchanged in Urine (Ae) of Digoxin
Day 7
|
0.123 mg
Geometric Coefficient of Variation 23.3
|
|
PK: Cumulative Amount of Drug Excreted Unchanged in Urine (Ae) of Digoxin
Day 16
|
0.148 mg
Geometric Coefficient of Variation 18.2
|
PRIMARY outcome
Timeframe: Day 7 and Day 16: Predose, 6, 12, 24 hours post dosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: Fe of Digoxin was reported. The urine sampling time points from pre-dose through 24 hours post-dose were used to assess this outcome.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Fraction of Digoxin Excreted Unchanged in Urine (Fe) Expressed as Percentage of Dose Excreted
Day 7
|
49.2 percentage of dose excreted in urine
Geometric Coefficient of Variation 23.3
|
|
PK: Fraction of Digoxin Excreted Unchanged in Urine (Fe) Expressed as Percentage of Dose Excreted
Day 16
|
59.4 percentage of dose excreted in urine
Geometric Coefficient of Variation 18.2
|
PRIMARY outcome
Timeframe: Day 7: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of digoxin had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: CLr of Digoxin in plasma was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Renal Clearance (CLr) of Digoxin in Plasma
Day 7
|
8.35 L/h
Geometric Coefficient of Variation 15.0
|
|
PK: Renal Clearance (CLr) of Digoxin in Plasma
Day 16
|
7.28 L/h
Geometric Coefficient of Variation 17.0
|
PRIMARY outcome
Timeframe: Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: AUC\[0-t\] of Pirtobrutinib was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Area Under the Concentration From Hour 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib in Plasma
Day 8
|
48400 h*ng/mL
Geometric Coefficient of Variation 16.3
|
|
PK: Area Under the Concentration From Hour 0 to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib in Plasma
Day 16
|
189000 h*ng/mL
Geometric Coefficient of Variation 25.8
|
PRIMARY outcome
Timeframe: Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: AUCtau of Pirtobrutinib was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Area Under the Concentration During a Dosing Interval (AUCtau) of Pirtobrutinib in Plasma
Day 8
|
48600 h*ng/mL
Geometric Coefficient of Variation 16.3
|
|
PK: Area Under the Concentration During a Dosing Interval (AUCtau) of Pirtobrutinib in Plasma
Day 16
|
106000 h*ng/mL
Geometric Coefficient of Variation 21.0
|
PRIMARY outcome
Timeframe: Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: CL/F of Pirtobrutinib in plasma was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=15 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib in Plasma
|
1.89 L/h
Geometric Coefficient of Variation 21.0
|
PRIMARY outcome
Timeframe: Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: Cmax of Pirtobrutinib was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib in Plasma
Day 16
|
7530 ng/mL
Geometric Coefficient of Variation 17.9
|
|
PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib in Plasma
Day 8
|
4330 ng/mL
Geometric Coefficient of Variation 17.1
|
PRIMARY outcome
Timeframe: Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: Tmax of Pirtobrutinib was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib in Plasma
Day 8
|
2.50 hours
Interval 1.0 to 3.0
|
|
PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib in Plasma
Day 16
|
2.50 hours
Interval 0.5 to 4.0
|
PRIMARY outcome
Timeframe: Day 8: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours postdose; Day 16: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours postdosePopulation: All enrolled population who had received at least one dose of Pirtobrutinib had at least one quantifiable PK concentration and for whom at least one PK parameter was computed. Number analyzed refer to participants evaluable at specified time points.
PK: MRT of Pirtobrutinib was reported.
Outcome measures
| Measure |
Digoxin + Pirtobrutinib
n=16 Participants
Participants received oral dose of
* 0.25 mg digoxin twice daily (BID) on Day 1
* 0.25 mg digoxin once daily (QD) from Day 2 to Day 7
* 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16
|
|---|---|
|
PK: Mean Residence Time (MRT) of Pirtobrutinib in Plasma
Day 8
|
22.6 hours
Geometric Coefficient of Variation 18.7
|
|
PK: Mean Residence Time (MRT) of Pirtobrutinib in Plasma
Day 16
|
30.5 hours
Geometric Coefficient of Variation 17.5
|
Adverse Events
0.25 mg Digoxin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
200 mg Pirtobrutinib + 0.25 mg Digoxin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.25 mg Digoxin
n=16 participants at risk
* Participants who received 0.25 mg digoxin orally BID on Day 1.
* Participants who received 0.25 mg digoxin orally QD from Day 2 to Day 7.
|
200 mg Pirtobrutinib + 0.25 mg Digoxin
n=16 participants at risk
* Participants who received 200 mg Pirtobrutinib in combination with 0.25 mg digoxin QD starting from Day 8 to Day 16.
|
|---|---|---|
|
Eye disorders
Visual impairment
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
General disorders
Medical device site erythema
|
12.5%
2/16 • Number of events 2 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
General disorders
Medical device site injury
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
General disorders
Medical device site pruritus
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.2%
1/16 • Number of events 1 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
0.00%
0/16 • Baseline up to Day 27
All participants who had received at least 1 dose of study drug. The adverse events were analyzed and reported according to the study treatment pre-specified in the statistical analysis plan.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60