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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134350
• Other study ID #: LOXO-BTK-20014
• Secondary ID: J2N-OX-JZNH
• Status: Completed
• Phase: Phase 1
• Start date: February 6, 2020
• Est. completion date: March 23, 2020

Study information

• Verified date: November 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Loxo Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	PK of LOXO-305	Pre-dose up to 168 hours post-dose
Primary	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)	PK of LOXO-305	Pre-dose up to 168 hours post-dose
Primary	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)	PK of LOXO-305	Pre-dose up to 168 hours post-dose
Primary	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	PK of LOXO-305	Pre-dose up to 168 hours post-dose
Primary	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	PK of LOXO-305	Pre-dose up to 168 hours post-dose
Primary	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	PK of LOXO-305	Pre-dose up to 168 hours post-dose