HealthyPhase 1NCT05176314

A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants

A Phase 1 study testing Rosuvastatin and Pirtobrutinib in people with Healthy, run by Loxo Oncology, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to determine the effect of pirtobrutinib on the levels of rosuvastatin in the blood stream in healthy participants. This study will also evaluate the safety and tolerability of rosuvastatin when administered in combination with pirtobrutinib in healthy participants. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Rosuvastatin and Pirtobrutinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 2 sitesUnited States
Study dates: 11 Jan 2022to 20 Apr 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs.
Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per meter squared (kg/m²) and a body weight of at least 50 kg.
Males, or female participants who are not of childbearing potential.

Who cannot join

Have known allergies to pirtobrutinib or rosuvastatin, related compounds, or any components of the formulation.
Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator.
Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorder or surgery (including cholecystectomy) capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, and/or herbal medications), or modulators of CYP3A4 or BCRP within 7 days prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
Have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined through genotyping.
Have c.521TC and c/521CC genotypes of SLCO1B1 as determined by genotyping.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Covance Dallas
Dallas, Texas, 75247
QPS Bio-Kinetic Clinical Applications
Springfield, Missouri, 65802

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single and Multiple Doses of Pirtobrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Conditions: Healthy
Being tested: Rosuvastatin, Pirtobrutinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosuvastatinDrug
Administered Orally.
PirtobrutinibDrug
Also called LY3527727
Administered Orally.

Study groups in NCT05176314
Study group	Role	What they receive
Rosuvastatin + Pirtobrutinib	Experimental	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. Receives: Drug: Rosuvastatin; Drug: Pirtobrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
PK: Cmax of Rosuvastatin
Measured: 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.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin
PK: AUC(0-inf) of Rosuvastatin
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 202220 Apr 2022

First posted4 Jan 2022
Study start11 Jan 2022
Primary completion20 Apr 2022
Study completion20 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05176314
Sponsor's protocol ID: 18366
Other IDs: J2N-MC-JZNW
Status last verified: May 2024
First submitted: 3 Jan 2022
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Drug Interaction Study to Investigate the Effect of Single and Multiple Doses of Pirtobrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
ClinicalTrials.gov ID: NCT05176314
Acronym / sponsor ID: 18366
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Loxo Oncology, Inc.Industry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 11 Jan 2022 (actual)
Primary completion: 20 Apr 2022 (actual)
Study completion: 20 Apr 2022 (actual)
First posted: 4 Jan 2022 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Rosuvastatin + Pirtobrutinib	Experimental	Drug: Rosuvastatin, Drug: PirtobrutinibParticipants 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.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and vital signs.
Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per meter squared (kg/m²) and a body weight of at least 50 kg.
Males, or female participants who are not of childbearing potential.

Key exclusion criteria (6 listed)

Have known allergies to pirtobrutinib or rosuvastatin, related compounds, or any components of the formulation.
Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator.
Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological, or psychiatric disorder or surgery (including cholecystectomy) capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, and/or herbal medications), or modulators of CYP3A4 or BCRP within 7 days prior to dosing, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
Have c.34AA, c.421AA, or c.34GA/421CA genotypes of ABCG2 as determined through genotyping.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RosuvastatinAdministered Orally.	Drug	Rosuvastatin + Pirtobrutinib
PirtobrutinibAlso: LY3527727Administered Orally.	Drug	Rosuvastatin + Pirtobrutinib

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin
Time frame: 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.
PK: Cmax of Rosuvastatin
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin
Time frame: 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.
PK: AUC(0-inf) of Rosuvastatin

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosuvastatin + Pirtobrutinib	32	28

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin

Time frame: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms per milliliter (ng/mL)

Measure	Rosuvastatin + Pirtobrutinib n = 31
Day 1	9.45 (56)
Day 6	23.0 (51)
Day 13	23.0 (49)

Population analysed: All randomized participants who received at least one dose of rosuvastatin and had evaluable PK data for the respective days for this outcome analysis.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of Rosuvastatin

Measure	Rosuvastatin + Pirtobrutinib n = 31
Day 1	88.2 (44)
Day 6	189 (41)
Day 13	207 (40)

Population analysed: All randomized participants who received at least one dose of rosuvastatin and had evaluable PK data for the respective days for this outcome analysis.

Adverse events

Time frame: Baseline to end of follow-up (up to 24 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20 mg Rosuvastatin (Day 1)	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)	0 of 32 (0%)	1 of 32 (3.1%)	0 of 32
200 mg Pirtobrutinib QD (Days 7-12)	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32
20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)	0 of 31 (0%)	0 of 31 (0%)	0 of 31
200 mg Pirtobrutinib QD (Days 14-17)	0 of 31 (0%)	1 of 31 (3.2%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rosuvastatin and Pirtobrutinib in people with Healthy, run by Loxo Oncology, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Rosuvastatin (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05176314.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.