Healthy VolunteersPhase 1NCT05134350
Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
A Phase 1 study testing LOXO-305 and Omeprazole in people with Healthy Volunteers, run by Loxo Oncology, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LOXO-305 and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 23 Mar 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- LOXO-305, Omeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOXO-305Drug
LOXO-305 orally.
OmeprazoleDrug
Omeprazole Orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1: ABC | Experimental | * Period 1: Single oral dose of 200 milligram (mg) LOXO-305 (Fasted state) on Day 1 (Treatment A)
* Period 2: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 8 (Treatment B)
* Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)
A washout period of 7 days was maintained between each treatment period. Receives: Drug: LOXO-305; Drug: Omeprazole |
| Treatment Sequence 2: BAC | Experimental | * Period 1: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 1 (Treatment B)
* Period 2: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 8 (Treatment A)
* Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C)
A washout period of 7 days was maintained between each treatment period. Receives: Drug: LOXO-305; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305
PK: AUC(0-24) hours of LOXO-305 is reported. AUC(0-24) was calculated by the linear trapezoidal method.
Measured: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post LOXO-305 dose
PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of LOXO-305
PK: AUC(0-t) of LOXO-305 is reported. AUC(0-t) was calculated by linear trapezoidal method.
Measured: 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 post LOXO-305 dose
PK: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC[0-Inf]) of LOXO-305
PK: AUC(0-inf) of LOXO-305 is reported. AUC(0-inf) was calculated using the formula: AUC(0-inf) = AUC(0-t) + Ct/λZ; where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant.
Measured: 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 post LOXO-305 dose
PK: Percentage Extrapolation for AUC0-Inf (%AUCextrap) of LOXO-305
PK: %AUCextrap of LOXO-305 is reported.
Measured: 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 post LOXO-305 dose
PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305
PK: Cmax of LOXO-305 is reported.
Measured: 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 post LOXO-305 dose
PK: Time to Maximum Observed Plasma Concentration (Tmax) of LOXO-305
PK: tmax of LOXO-305 is reported.
Measured: 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 post LOXO-305 dose
PK: Apparent Terminal Elimination Half-life (t½) of LOXO-305
PK: t½ of LOXO-305 is reported.
Measured: 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 post LOXO-305 dose
PK: Apparent Systemic Clearance (CL/F) of LOXO-305
PK: CL/F of LOXO-305 is reported.
Measured: 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 post LOXO-305 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start6 Feb 2020
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loxo Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Renée Ward, MD, PhD, Study director, Loxo Oncology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134350
- Sponsor's protocol ID
- LOXO-BTK-20014
- Other IDs
- J2N-OX-JZNH
- Status last verified
- Nov 2024
- First submitted
- 22 Oct 2021
- Last updated
- 10 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05134350
- Acronym / sponsor ID
- LOXO-BTK-20014
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Loxo Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Posted 10 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1: ABC | Experimental | Drug: LOXO-305, Drug: Omeprazole* Period 1: Single oral dose of 200 milligram (mg) LOXO-305 (Fasted state) on Day 1 (Treatment A) * Period 2: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 8 (Treatment B) * Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C) A washout period of 7 days was maintained between each treatment period. |
| Treatment Sequence 2: BAC | Experimental | Drug: LOXO-305, Drug: Omeprazole* Period 1: Single oral dose of 200 mg LOXO-305 (Fed state) on Day 1 (Treatment B) * Period 2: Single oral dose of 200 mg LOXO-305 (Fasted state) on Day 8 (Treatment A) * Period 3: Single oral dose of 40 mg Omeprazole (Fasted state) on Day 15 to 17 and single oral dose of 200 mg LOXO-305 + 40 mg Omeprazole (Fasted state) on Day 18 (Treatment C) A washout period of 7 days was maintained between each treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- History or presence of any of the following, deemed clinically significant by the Investigator (or designee), and/or Sponsor:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOXO-305LOXO-305 orally. | Drug | Treatment Sequence 1: ABC, Treatment Sequence 2: BAC |
| OmeprazoleOmeprazole Orally. | Drug | Treatment Sequence 1: ABC, Treatment Sequence 2: BAC |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305
Time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post LOXO-305 dose
PK: AUC(0-24) hours of LOXO-305 is reported. AUC(0-24) was calculated by the linear trapezoidal method.
PK: Area Under the Concentration-time Curve From Hour 0 to the Last Measurable Concentration (AUC[0-t]) of LOXO-305
Time frame: 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 post LOXO-305 dose
PK: AUC(0-t) of LOXO-305 is reported. AUC(0-t) was calculated by linear trapezoidal method.
PK: Area Under the Concentration-time Curve Extrapolated to Infinity (AUC[0-Inf]) of LOXO-305
Time frame: 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 post LOXO-305 dose
PK: AUC(0-inf) of LOXO-305 is reported. AUC(0-inf) was calculated using the formula: AUC(0-inf) = AUC(0-t) + Ct/λZ; where Ct is the last measurable concentration and λZ is the apparent terminal elimination rate constant.
PK: Percentage Extrapolation for AUC0-Inf (%AUCextrap) of LOXO-305
Time frame: 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 post LOXO-305 dose
PK: %AUCextrap of LOXO-305 is reported.
PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305
Time frame: 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 post LOXO-305 dose
PK: Cmax of LOXO-305 is reported.
PK: Time to Maximum Observed Plasma Concentration (Tmax) of LOXO-305
Time frame: 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 post LOXO-305 dose
PK: tmax of LOXO-305 is reported.
PK: Apparent Terminal Elimination Half-life (t½) of LOXO-305
Time frame: 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 post LOXO-305 dose
PK: t½ of LOXO-305 is reported.
PK: Apparent Systemic Clearance (CL/F) of LOXO-305
Time frame: 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 post LOXO-305 dose
PK: CL/F of LOXO-305 is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renée Ward, MD, PhD study director
Loxo Oncology, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LOXO-305 and Omeprazole in people with Healthy Volunteers, run by Loxo Oncology, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Concentration-time Curve From Hour 0 to 24 (AUC [0-24]) Hours of LOXO-305 (time frame: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post LOXO-305 dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.