NCT05134337 is a Phase 1 clinical trial of LOXO-305 in Healthy Volunteers, sponsored by Loxo Oncology, Inc..

Who is sponsoring NCT05134337?

NCT05134337 is sponsored by Loxo Oncology, Inc..

What drugs are being tested in NCT05134337?

Interventions in NCT05134337: LOXO-305, Itraconazole, Rifampin.

What condition does NCT05134337 study?

NCT05134337 studies Healthy Volunteers.

Is NCT05134337 still recruiting?

NCT05134337 is currently completed. Last updated 9 January 2025.

Are results published for NCT05134337?

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

Last reviewed 2025-01-09 · How we verify

NCT05134337

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

Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants

Completed Phase 1 Results posted Last updated 9 January 2025

What this trial tests

Phase 1 trial testing LOXO-305 in Healthy Volunteers in 27 participants. Completed in 30 October 2020.

Timeline

12 February 2020

Primary endpoint
30 October 2020

30 October 2020

Quick facts

Lead sponsor	Loxo Oncology, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	basic science
Enrollment	27
Start date	12 February 2020
Primary completion	30 October 2020
Estimated completion	30 October 2020
Sites	1 location across United States

Drugs / interventions tested

LOXO-305 — full drug profile →
Itraconazole — full drug profile →
Rifampin — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Loxo Oncology, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. 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.

Part 1: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LOXO-305 Primary · Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 12

Cmax of LOXO-305

Day 1

Group	Value	95% CI
Part 1 (LOXO-305/Itraconazole)	4000	± 23.5

Day 12

Group	Value	95% CI
Part 1 (LOXO-305/Itraconazole)	4100	± 17.2

Part 1: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305 Primary · Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 12

PK: AUC0-t of LOXO 305

Day 1

Group	Value	95% CI
Part 1 (LOXO-305/Itraconazole)	80000	± 23.4

Day 12

Group	Value	95% CI
Part 1 (LOXO-305/Itraconazole)	122000	± 22.7

Part 1: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of LOXO-305 Primary · Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 12

AUC0-inf of LOXO-305

Day 1

Group	Value	95% CI
Part 1 (LOXO-305/Itraconazole)	80800	± 23.4

Day 12

Group	Value	95% CI
Part 1 (LOXO-305/Itraconazole)	123000	± 23.4

Part 2: PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305 Primary · Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 17; Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose on day 8

Cmax of LOXO-305

Day 1

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	4480	± 20.4

Day 8

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	4170	± 15.6

Day 17

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	2580	± 22.4

Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305 Primary · Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 17; Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose on day 8

PK: AUC0-t of LOXO 305

Day 1

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	79700	± 17.6

Day 8

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	48500	± 14.7

Day 17

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	23000	± 20.1

Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of LOXO-305 Primary · Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 17

AUC0-inf of LOXO-305

Day 1

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	80600	± 17.3

Day 17

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	23600	± 19.8

Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of LOXO-305 Primary · Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose on days 1 and 8

AUC0-24 of LOXO-305

Day 1

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	50200	± 14.5

Day 8

Group	Value	95% CI
Part 2 (LOXO 305/Rifampin)	48600	± 14.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: 200 mg LOXO-305 Alone

Serious: 0/15 (0%)

Deaths: 0/15

Part 1: 200 mg Itraconazole Alone

Serious: 0/12 (0%)

Deaths: 0/12

Part 1: 200 mg LOXO-305 + 200 mg Itraconazole

Serious: 0/12 (0%)

Deaths: 0/12

Part 2: 200 mg LOXO-305 Alone

Serious: 0/12 (0%)

Deaths: 0/12

Part 2: 200 mg LOXO-305 (Day 8) + 600 mg Rifampin

Serious: 0/12 (0%)

Deaths: 0/12

Part 2: 200 mg LOXO-305 (Day 17) + 600 mg Rifampin

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (7 terms — click to expand)

Reaction	System	Part 1: 200 mg LOXO-305 Al…	Part 1: 200 mg Itraconazol…	Part 1: 200 mg LOXO-305 + …	Part 2: 200 mg LOXO-305 Al…	Part 2: 200 mg LOXO-305 (D…	Part 2: 200 mg LOXO-305 (D…
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—
Aphthous ulcer	Gastrointestinal disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Eructation	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—	—
Muscle twitching	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT05134337 adverse events section.

Sponsor's own description

The main purpose of this study is to learn about how itraconazole and rifampin affect LOXO-305 in healthy participants. Participation could last about 8 weeks.

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 LOXO-305

Trials testing the same drug.

NCT04849416 — A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia) · Phase 2 · completed
NCT06180954 — A Study of Carbon-14-Labelled [14C] LOXO-305 (Pirtobrutinib) in Healthy Male Participants · Phase 1 · completed
NCT05134350 — Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants · Phase 1 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

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NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other Loxo Oncology, Inc. trials

Trials by the same sponsor.

NCT06104683 — A Study of Pirtobrutinib (LY3527727 [LOXO-305]) Versus Placebo in Participants With Relapsing Multiple Sclerosis · Phase 2 · withdrawn
NCT05324124 — A Study of the Effect of Food on Selpercatinib (LY3527723) in Healthy Participants · Phase 1 · completed
NCT05176314 — A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants · Phase 1 · completed
NCT05136404 — A Relative Bioavailability Study of Selpercatinib (LY3527723) in Healthy Participants · Phase 1 · completed
NCT05089019 — A Study Comparing Two Formulations of Selpercatinib (LY3527723) 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 NCT05134337 (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 Loxo Oncology, Inc.
Last refreshed: 9 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/NCT05134337.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05134337

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 LOXO-305

Other recruiting trials for Healthy Volunteers

Other Loxo Oncology, Inc. trials

Verify against primary sources