Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants

Overview

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.

Full Title of Study: “A Phase 1, Open Label, Randomized, 2-Way Crossover, 3-Period Study to Evaluate the Effect of Food and a Proton Pump Inhibitor on the Pharmacokinetics of LOXO-305 in Healthy Adult Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 23, 2020

Interventions

  • Drug: LOXO-305
    • Oral LOXO-305
  • Drug: Omeprazole
    • Oral omeprazole

Arms, Groups and Cohorts

  • Experimental: Arm A (LOXO-305 – Fasted)
    • LOXO-305 administered orally while fasting
  • Experimental: Arm B (LOXO-305 – Fed)
    • LOXO-305 administered orally with standard meal
  • Experimental: Arm C (Omeprazole + LOXO-305 Fasted)
    • Omeprazole + LOXO-305 administered orally while fasting

Clinical Trial Outcome Measures

Primary Measures

  • Assess effect of food on pharmacokinetics (PK) of LOXO-305 administered when fasted and after standard meal by collecting/evaluating serum at protocol-specified time points: Maximum observed plasma concentration (Cmax)
    • Time Frame: Pre-dose up to 168 hours post-dose
    • PK of LOXO-305
  • Assess effect of food on PK of LOXO-305 administered when fasted and after standard meal by collecting/evaluating serum at protocol-specified time points: Area under the concentration-time curve from Hour 0 to last measurable concentration (AUC0-t)
    • Time Frame: Pre-dose up to 168 hours post-dose
    • PK of LOXO-305
  • Assess effect of food on PK of LOXO-305 administered when fasted and after standard meal by collecting/evaluating serum at protocol-specified time points: Area under the concentration-time curve extrapolated to infinity (AUC0-inf)
    • Time Frame: Pre-dose up to 168 hours post-dose
    • PK of LOXO-305
  • 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
    • Time Frame: Pre-dose up to 168 hours post-dose
    • PK of LOXO-305
  • 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
    • Time Frame: Pre-dose up to 168 hours post-dose
    • PK of LOXO-305
  • 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
    • Time Frame: Pre-dose up to 168 hours post-dose
    • PK of LOXO-305

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Loxo Oncology, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Renée Ward, MD, PhD, Study Director, Loxo Oncology, Inc.

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