NCT06181006 is a Phase 1 clinical trial of Pirtobrutinib in Healthy, sponsored by Eli Lilly and Company.

Who is sponsoring NCT06181006?

NCT06181006 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT06181006?

Interventions in NCT06181006: Pirtobrutinib.

Is NCT06181006 still recruiting?

NCT06181006 is currently completed. Last updated 14 January 2025.

Are results published for NCT06181006?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-01-14 · How we verify

NCT06181006

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants

Completed Phase 1 Results posted Last updated 14 January 2025

What this trial tests

Phase 1 trial testing Pirtobrutinib in Healthy in 24 participants. Completed in 1 December 2020.

Timeline

14 August 2020

Primary endpoint
1 December 2020

1 December 2020

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	24
Start date	14 August 2020
Primary completion	1 December 2020
Estimated completion	1 December 2020
Sites	1 location across United States

Drugs / interventions tested

Pirtobrutinib — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Primary · Baseline up to 46 days

TEAE is defined as an adverse event (AE) which starts on or after the first administration of study drug. A serious adverse event is defined as any AE occurring at any dose that results in any of the following outcomes: death; a life-threatening adverse drug experience; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; an important medical event that may require medical or surgical intervention to prevent any of the above outcomes.

TEAEs

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	1
Cohort 2: 600 mg Pirtobrutinib	0
Cohort 3: 800 mg Pirtobrutinib	0
Cohort 4: 900 mg Pirtobrutinib	3

SAEs

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	0
Cohort 2: 600 mg Pirtobrutinib	0
Cohort 3: 800 mg Pirtobrutinib	0
Cohort 4: 900 mg Pirtobrutinib	0

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib Secondary · Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24 hours post-dose)

PK: AUC0-24 of Pirtobrutinib.

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	84100	± 27.2
Cohort 2: 600 mg Pirtobrutinib	135000	± 81.8
Cohort 3: 800 mg Pirtobrutinib	200000	± 22.6
Cohort 4: 900 mg Pirtobrutinib	225000	± 22.3

PK: Area Under the Concentration Versus Time Curve From Hour Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: AUC0-t of Pirtobrutinib.

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	143000	± 29.8
Cohort 2: 600 mg Pirtobrutinib	259000	± 101
Cohort 3: 800 mg Pirtobrutinib	379000	± 16.9
Cohort 4: 900 mg Pirtobrutinib	490000	± 26.8

PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: AUC0-inf of Pirtobrutinib.

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	144000	± 30.1
Cohort 2: 600 mg Pirtobrutinib	260000	± 100
Cohort 3: 800 mg Pirtobrutinib	382000	± 16.9
Cohort 4: 900 mg Pirtobrutinib	492000	± 26.9

PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: %AUCextrap of pirtobrutinib.

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	0.869	± 39.9
Cohort 2: 600 mg Pirtobrutinib	0.504	± 61.2
Cohort 3: 800 mg Pirtobrutinib	0.474	± 113
Cohort 4: 900 mg Pirtobrutinib	0.458	± 48.1

PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: Cmax of Pirtobrutinib.

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	6600	± 28.7
Cohort 2: 600 mg Pirtobrutinib	9050	± 65.9
Cohort 3: 800 mg Pirtobrutinib	13700	± 32.8
Cohort 4: 900 mg Pirtobrutinib	13000	± 27.1

PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: Tmax of Pirtobrutinib.

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	3.25	1.50 – 7.00
Cohort 2: 600 mg Pirtobrutinib	2.75	2.00 – 4.00
Cohort 3: 800 mg Pirtobrutinib	3.00	2.50 – 7.00
Cohort 4: 900 mg Pirtobrutinib	4.01	2.50 – 9.00

PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 1) Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: λZ of Pirtobrutinib.

Subject 1

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	0.0367

Subject 2

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	0.0423

Subject 3

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	0.0242

Subject 4

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	0.0477

Subject 5

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	0.0285

Subject 6

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	0.0469

PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 2) Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: λZ of Pirtobrutinib.

Subject 1

Group	Value	95% CI
Cohort 2: 600 mg Pirtobrutinib	0.0322

Subject 2

Group	Value	95% CI
Cohort 2: 600 mg Pirtobrutinib	0.0317

Subject 3

Group	Value	95% CI
Cohort 2: 600 mg Pirtobrutinib	0.0381

Subject 4

Group	Value	95% CI
Cohort 2: 600 mg Pirtobrutinib	0.0327

Subject 5

Group	Value	95% CI
Cohort 2: 600 mg Pirtobrutinib	0.0353

Subject 6

Group	Value	95% CI
Cohort 2: 600 mg Pirtobrutinib	0.0368

PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 3) Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: λZ of Pirtobrutinib.

Subject 1

Group	Value	95% CI
Cohort 3: 800 mg Pirtobrutinib	0.0279

Subject 2

Group	Value	95% CI
Cohort 3: 800 mg Pirtobrutinib	0.0263

Subject 3

Group	Value	95% CI
Cohort 3: 800 mg Pirtobrutinib	0.0339

Subject 4

Group	Value	95% CI
Cohort 3: 800 mg Pirtobrutinib	0.0339

Subject 5

Group	Value	95% CI
Cohort 3: 800 mg Pirtobrutinib	0.0295

Subject 6

Group	Value	95% CI
Cohort 3: 800 mg Pirtobrutinib	0.0410

PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 4) Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: λZ of Pirtobrutinib.

Subject 1

Group	Value	95% CI
Cohort 4: 900 mg Pirtobrutinib	0.0291

Subject 2

Group	Value	95% CI
Cohort 4: 900 mg Pirtobrutinib	0.0367

Subject 3

Group	Value	95% CI
Cohort 4: 900 mg Pirtobrutinib	0.0330

Subject 4

Group	Value	95% CI
Cohort 4: 900 mg Pirtobrutinib	0.0313

Subject 5

Group	Value	95% CI
Cohort 4: 900 mg Pirtobrutinib	0.0320

Subject 6

Group	Value	95% CI
Cohort 4: 900 mg Pirtobrutinib	0.0396

PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib Secondary · Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)

PK: CL/F of Pirtobrutinib.

Group	Value	95% CI
Cohort 1: 300 mg Pirtobrutinib	2.08	± 30.1
Cohort 2: 600 mg Pirtobrutinib	2.31	± 100
Cohort 3: 800 mg Pirtobrutinib	2.10	± 16.9
Cohort 4: 900 mg Pirtobrutinib	1.83	± 26.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Upto 46 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: 300 mg Pirtobrutinib

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 2: 600 mg Pirtobrutinib

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 3: 800 mg Pirtobrutinib

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 4: 900 mg Pirtobrutinib

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (2 terms — click to expand)

Reaction	System	Cohort 1: 300 mg Pirtobrut…	Cohort 2: 600 mg Pirtobrut…	Cohort 3: 800 mg Pirtobrut…	Cohort 4: 900 mg Pirtobrut…
Headache	Nervous system disorders	—	—	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT06181006 adverse events section.

Sponsor's own description

The main purpose of this study is to assess the safety and tolerability of pirtobrutinib and to look at the amount of the study drug, pirtobrutinib, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 46 days, including screening.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Pirtobrutinib

Trials testing the same drug.

NCT07525817 — A Real-World Study of Pirtobrutinib in cBTKi-Resistant/Intolerant Mature B-Cell Lymphoma · not yet recruiting
NCT07428707 — Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib · EARLY_PHASE1 · recruiting
NCT07207785 — PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma · Phase 2 · not yet recruiting
NCT07342478 — ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL · Phase 3 · not yet recruiting
NCT07255963 — Pirtobrutinib, Lisaftoclax, and Rituximab in the Treatment of R/R DLBCL · Phase 2 · recruiting

Other recruiting trials for Healthy

Currently open trials in the same condition.

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Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06181006 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 14 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06181006.

NCT06181006

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Pirtobrutinib

Other recruiting trials for Healthy

Other Eli Lilly and Company trials

Verify against primary sources