Phase 1
Completed N=10
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT05134350 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305 — 55100; 51900; 59900 hour*nanograms per milliliter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305 |
55100; 51900; 59900 | — |
| PRIMARY PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of LOXO-305 |
89400; 85100; 99600 | — |
| PRIMARY PK: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC[0-Inf]) of LOXO-305 |
90200; 86100; 101000 | — |
| PRIMARY PK: Percentage Extrapolation for AUC0-Inf (%AUCextrap) of LOXO-305 |
0.911; 1.12; 0.893 | — |
| PRIMARY PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305 |
5450; 4340; 5490 | — |
| PRIMARY PK: Time to Maximum Observed Plasma Concentration (Tmax) of LOXO-305 |
2.50; 3.00; 2.25 | — |
| PRIMARY PK: Apparent Terminal Elimination Half-life (t½) of LOXO-305 |
20.2; 21.5; 19.7 | — |
| PRIMARY PK: Apparent Systemic Clearance (CL/F) of LOXO-305 |
2.22; 2.32; 1.99 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females of non-childbearing potential.
- Within body mass index (BMI) range 18.0 to 32.0 kilograms per square meter (kg/m²).
- Participants will be in good general health, based on medical history, physical examination findings, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests, as determined by the Investigator (or designee).
- Able to comply with all study procedures, including the 25-night stay at the Clinical Research Unit and follow-up phone call.
Exclusion Criteria
- History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
- liver disease
- pancreatitis
- peptic ulcer disease
- intestinal malabsorption
- gastric reduction surgery
- history or presence of clinically significant cardiovascular disease.
- Participants with out-of-range, at-rest vital signs.
- Abnormal laboratory values determined to be clinically significant by the Investigator (or designee), and Sponsor.
- Clinically significant abnormality, as determined by the Investigator (or designee), from physical examination.
- Participation in any other investigational study drug trial involving administration of any investigational drug in the past 30 days or 5 half-lives, whichever was longer, prior to the first dose administration (Day 1).
- Use or intention to use any prescription or over-the-counter medications within 14 days prior to the first dose administration (Day 1) through the end of the trial.
- History or presence, upon clinical evaluation, of any illness that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results, or put the participant at undue risk.
- Donation of blood from 56 days prior to Screening, plasma or platelets from 4 weeks prior to Screening.
- Receipt of blood products within 2 months prior to Check-in (Day -1).
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular (including any prior history of cardiomyopathy or cardiac failure), GI, neurological, or psychiatric disorder (as determined by the Investigator), or cancer within the past 5 years (except localized basal cell, squamous, or in situ cancer of the skin).
Data sourced from ClinicalTrials.gov (NCT05134350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.