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Kinase Inhibitor

Arm B (LOXO-305 - Fed) for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Loxo Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose up to 168 hours post-dose
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The main purpose of this study is to learn about how food and a PPI (omeprazole) affect LOXO-305 in healthy participants. Participation could last about nine weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose up to 168 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose up to 168 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess effect of a gastric pH change on the PK of LOXO-305 after multiple doses of a PPI (omeprazole) by collecting/evaluating serum at protocol-specified time points: AUC0-inf
Assess effect of a gastric pH change on the PK of LOXO-305 after multiple doses of a PPI (omeprazole) by collecting/evaluating serum at protocol-specified time points: AUC0-t
Assess effect of a gastric pH change on the PK of LOXO-305 after multiple doses of a PPI (omeprazole) by collecting/evaluating serum at protocol-specified time points: Cmax
+3 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (Omeprazole + LOXO-305 Fasted)Experimental Treatment2 Interventions
Omeprazole + LOXO-305 administered orally while fasting
Group II: Arm B (LOXO-305 - Fed)Experimental Treatment1 Intervention
LOXO-305 administered orally with standard meal
Group III: Arm A (LOXO-305 - Fasted)Experimental Treatment1 Intervention
LOXO-305 administered orally while fasting
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOXO-305
2021
Completed Phase 1
~60
Omeprazole
FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Loxo Oncology, Inc.Lead Sponsor
71 Previous Clinical Trials
11,069 Total Patients Enrolled
Renée Ward, MD, PhDStudy DirectorLoxo Oncology, Inc.
3 Previous Clinical Trials
76 Total Patients Enrolled
~2 spots leftby Nov 2025
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