Trial Outcomes & Findings for A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants (NCT NCT05176314)
NCT ID: NCT05176314
Last Updated: 2024-09-19
Results Overview
PK: Cmax of Rosuvastatin
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose.
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Rosuvastatin + Pirtobrutinib
Participants received study intervention through oral administration as follows:
* Day 1: 20 milligram (mg) rosuvastatin alone
* Day 6: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 7 to 12: Once daily (QD) doses of 200 mg pirtobrutinib alone
* Day 13: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 14 to 17: QD doses of 200 mg pirtobrutinib alone.
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
Safety Population Day 1, Day 6 and Days 7-12
|
32
|
|
Overall Study
Safety Population Day 13, Days 14-17
|
31
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Rosuvastatin + Pirtobrutinib
Participants received study intervention through oral administration as follows:
* Day 1: 20 milligram (mg) rosuvastatin alone
* Day 6: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 7 to 12: Once daily (QD) doses of 200 mg pirtobrutinib alone
* Day 13: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 14 to 17: QD doses of 200 mg pirtobrutinib alone.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Rosuvastatin + Pirtobrutinib
n=32 Participants
Participants received study intervention through oral administration as follows:
* Day 1: 20 milligram (mg) rosuvastatin alone
* Day 6: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 7 to 12: Once daily (QD) doses of 200 mg pirtobrutinib alone
* Day 13: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 14 to 17: QD doses of 200 mg pirtobrutinib alone.
|
|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose.Population: All randomized participants who received at least one dose of rosuvastatin and had evaluable PK data for the respective days for this outcome analysis.
PK: Cmax of Rosuvastatin
Outcome measures
| Measure |
Rosuvastatin + Pirtobrutinib
n=31 Participants
Participants received study intervention through oral administration as follows:
* Day 1: 20 milligram (mg) rosuvastatin alone
* Day 6: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 7 to 12: Once daily (QD) doses of 200 mg pirtobrutinib alone
* Day 13: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 14 to 17: QD doses of 200 mg pirtobrutinib alone.
|
|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
Day 1
|
9.45 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
Day 6
|
23.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
Day 13
|
23.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
PRIMARY outcome
Timeframe: Day 1, Day 6 and Day 13: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120 hours (h) post-dose.Population: All randomized participants who received at least one dose of rosuvastatin and had evaluable PK data for the respective days for this outcome analysis.
PK: AUC(0-inf) of Rosuvastatin
Outcome measures
| Measure |
Rosuvastatin + Pirtobrutinib
n=31 Participants
Participants received study intervention through oral administration as follows:
* Day 1: 20 milligram (mg) rosuvastatin alone
* Day 6: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 7 to 12: Once daily (QD) doses of 200 mg pirtobrutinib alone
* Day 13: 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib
* Days 14 to 17: QD doses of 200 mg pirtobrutinib alone.
|
|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin
Day 1
|
88.2 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 44
|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin
Day 6
|
189 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 41
|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin
Day 13
|
207 nanograms*hours per milliliter(ng*h/mL)
Geometric Coefficient of Variation 40
|
Adverse Events
20 mg Rosuvastatin (Day 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
200 mg Pirtobrutinib QD (Days 7-12)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
200 mg Pirtobrutinib QD (Days 14-17)
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 |
20 mg Rosuvastatin (Day 1)
n=32 participants at risk
Participants received 20 milligram (mg) rosuvastatin alone on day 1 through oral administration.
|
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)
n=32 participants at risk
Participants received 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib on day 6 through oral administration.
|
200 mg Pirtobrutinib QD (Days 7-12)
n=32 participants at risk
Participants received once daily (QD) doses of 200 mg pirtobrutinib alone on days 7 to 12 through oral administration.
|
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)
n=31 participants at risk
Participants received 20 mg rosuvastatin co-administered with 200 mg pirtobrutinib on day 13 through oral administration.
|
200 mg Pirtobrutinib QD (Days 14-17)
n=31 participants at risk
Participants received QD doses of 200 mg pirtobrutinib alone on days 14 to 17 through oral administration.
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
9.4%
3/32 • Number of events 4 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
0.00%
0/32 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
3.1%
1/32 • Number of events 1 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
0.00%
0/31 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
0.00%
0/31 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/32 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
3.1%
1/32 • Number of events 1 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
9.4%
3/32 • Number of events 3 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
0.00%
0/31 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
3.2%
1/31 • Number of events 1 • Baseline to end of follow-up (up to 24 days).
All participants from the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60