Healthy VolunteersPhase 1NCT03901313

Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers

A Phase 1 study testing Treatment A - 400 mg Fasting, Treatment B - 400 mg Fed and Treatment C - 200 mg Fed in people with Healthy Volunteers, run by Daiichi Sankyo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

All participants in this study are healthy volunteers. Throughout the study, healthy volunteers will have physical exams, electrocardiograms and clinical laboratory tests. The study staff will keep track of symptoms, diet, and what medications they are taking. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Treatment A - 400 mg Fasting, Treatment B - 400 mg Fed and Treatment C - 200 mg Fed
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 1 Apr 2019to 22 May 2019
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is healthy at screening visit
Is not pregnant or lactating
Is surgically or naturally unable to reproduce, or agrees to remain sexually abstinent or to use double barrier methods of contraception from check-in until 90 days after the final dose of pexidartinib
Has a Body Mass Index (BMI) of 18-30 kg/m^2, inclusive
Has negative test results for protocol-defined drugs and diseases at screening and/or check-in
Is willing to avoid food or beverages before check-in until the end of the study:
containing caffeine/xanthine or alcohol from 48 hours before check-in
containing grapefruit or Seville oranges 6 days before check-in

Who cannot join

Per protocol or in the opinion of the investigator at screening and/or check-in, has something that would preclude participation:
has a clinically significant disorder, disease or lab value
consumes a prohibited drug, drink or food
is unable to consume the standard meal
Is an employee of the clinic or their family member

Trial locations and contacts

1 site in 1 country.

United States1 site

Worldwide Clinical Trials
San Antonio, Texas, 78217

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Randomized, 3-Period Crossover Study to Assess the Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Subjects

All participants in this study are healthy volunteers.

Throughout the study, healthy volunteers will have physical exams, electrocardiograms and clinical laboratory tests. The study staff will keep track of symptoms, diet, and what medications they are taking.

Each participant will get all three treatments (A, B and C). Only the order in which they receive them will be different.

There are six groups based on the order: ABC, ACB, BAC, BCA, CAB, or CBA. Participants have an equal chance of being assigned to any of these groups.

For each treatment period, participants will:

fast overnight
receive the assigned treatment with or without food
have a small tube of blood drawn prior to treatment
after dosing, additional blood samples will be drawn at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours
have a break from treatment for 6 days between each treatment period

All participants must reside in the clinic for a total of 20 days.

Read the detailed description

The primary objectives of this study are:

To assess the effect of low-fat food on the pharmacokinetics (PK) of pexidartinib following a single oral dose of 400 mg administered in healthy subjects
To assess the PK of pexidartinib following a single oral dose of 200 mg administered with low-fat food in healthy subjects

The secondary objective of this study is:

To characterize the safety and tolerability of pexidartinib in healthy subjects following administration of a single oral dose of pexidartinib with low fat food and without food

Conditions: Healthy Volunteers
Being tested: Treatment A - 400 mg Fasting, Treatment B - 400 mg Fed, Treatment C - 200 mg Fed
Keywords: Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A - 400 mg FastingDrug
Also called Pexidartinib
Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions
Treatment B - 400 mg FedDrug
Also called Pexidartinib
Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal
Treatment C - 200 mg FedDrug
Also called Pexidartinib
Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Study groups in NCT03901313
Study group	Role	What they receive
Sequence ABC	Experimental	Healthy volunteers will receive Treatments A, then B, and then C, with a 6-day washout between treatments, during a stay at the clinic of 20 days Receives: Drug: Treatment A - 400 mg Fasting; Drug: Treatment B - 400 mg Fed; Drug: Treatment C - 200 mg Fed
Sequence ACB	Experimental	Healthy volunteers will receive Treatments A, then C, and then B, with a 6-day washout between treatments, during a stay at the clinic of 20 days Receives: Drug: Treatment A - 400 mg Fasting; Drug: Treatment B - 400 mg Fed; Drug: Treatment C - 200 mg Fed
Sequence BAC	Experimental	Healthy volunteers will receive Treatments B, then A, and then C, with a 6-day washout between treatments, during a stay at the clinic of 20 days Receives: Drug: Treatment A - 400 mg Fasting; Drug: Treatment B - 400 mg Fed; Drug: Treatment C - 200 mg Fed
Sequence BCA	Experimental	Healthy volunteers will receive Treatments B, then C, and then A, with a 6-day washout between treatments, during a stay at the clinic of 20 days Receives: Drug: Treatment A - 400 mg Fasting; Drug: Treatment B - 400 mg Fed; Drug: Treatment C - 200 mg Fed
Sequence CAB	Experimental	Healthy volunteers will receive Treatments C, then A, and then B, with a 6-day washout between treatments, during a stay at the clinic of 20 days Receives: Drug: Treatment A - 400 mg Fasting; Drug: Treatment B - 400 mg Fed; Drug: Treatment C - 200 mg Fed
Sequence CBA	Experimental	Healthy volunteers will receive Treatments C, then B, and then A, with a 6-day washout between treatments, during a stay at the clinic of 20 days Receives: Drug: Treatment A - 400 mg Fasting; Drug: Treatment B - 400 mg Fed; Drug: Treatment C - 200 mg Fed

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib
Mean Cmax of pexidartinib is calculated for each treatment period
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose
Time to Cmax (Tmax)
Median Tmax of pexidartinib is calculated for each treatment period
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose
Area Under the Concentration-time Curve From Time of Dosing to Last Measurable Concentration (AUClast) and to Infinity (AUCinf)
Mean AUClast and AUCinf for pexidartinib are calculated for each treatment period
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose
Terminal Half-life (t1/2)
Mean t1/2 for pexidartinib is calculated for each treatment period
Measured: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201922 May 2019

First posted3 Apr 2019
Study start1 Apr 2019
Primary completion8 May 2019
Study completion22 May 2019

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.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
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: Sequential
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03901313
Sponsor's protocol ID: PL3397-A-U128
Status last verified: Apr 2020
First submitted: 1 Apr 2019
Last updated: 11 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Randomized, 3-Period Crossover Study to Assess the Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Subjects
ClinicalTrials.gov ID: NCT03901313
Acronym / sponsor ID: PL3397-A-U128
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: 1 Apr 2019 (actual)
Primary completion: 8 May 2019 (actual)
Study completion: 22 May 2019 (actual)
First posted: 3 Apr 2019 (actual)
Results: Posted 22 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

All participants in this study are healthy volunteers.

Each participant will get all three treatments (A, B and C). Only the order in which they receive them will be different.

There are six groups based on the order: ABC, ACB, BAC, BCA, CAB, or CBA. Participants have an equal chance of being assigned to any of these groups.

For each treatment period, participants will:

fast overnight
receive the assigned treatment with or without food
have a small tube of blood drawn prior to treatment
after dosing, additional blood samples will be drawn at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours
have a break from treatment for 6 days between each treatment period

All participants must reside in the clinic for a total of 20 days.

Detailed description

The primary objectives of this study are:

To assess the effect of low-fat food on the pharmacokinetics (PK) of pexidartinib following a single oral dose of 400 mg administered in healthy subjects
To assess the PK of pexidartinib following a single oral dose of 200 mg administered with low-fat food in healthy subjects

The secondary objective of this study is:

To characterize the safety and tolerability of pexidartinib in healthy subjects following administration of a single oral dose of pexidartinib with low fat food and without food

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence ABC	Experimental	Drug: Treatment A - 400 mg Fasting, Drug: Treatment B - 400 mg Fed, Drug: Treatment C - 200 mg FedHealthy volunteers will receive Treatments A, then B, and then C, with a 6-day washout between treatments, during a stay at the clinic of 20 days
Sequence ACB	Experimental	Drug: Treatment A - 400 mg Fasting, Drug: Treatment B - 400 mg Fed, Drug: Treatment C - 200 mg FedHealthy volunteers will receive Treatments A, then C, and then B, with a 6-day washout between treatments, during a stay at the clinic of 20 days
Sequence BAC	Experimental	Drug: Treatment A - 400 mg Fasting, Drug: Treatment B - 400 mg Fed, Drug: Treatment C - 200 mg FedHealthy volunteers will receive Treatments B, then A, and then C, with a 6-day washout between treatments, during a stay at the clinic of 20 days
Sequence BCA	Experimental	Drug: Treatment A - 400 mg Fasting, Drug: Treatment B - 400 mg Fed, Drug: Treatment C - 200 mg FedHealthy volunteers will receive Treatments B, then C, and then A, with a 6-day washout between treatments, during a stay at the clinic of 20 days
Sequence CAB	Experimental	Drug: Treatment A - 400 mg Fasting, Drug: Treatment B - 400 mg Fed, Drug: Treatment C - 200 mg FedHealthy volunteers will receive Treatments C, then A, and then B, with a 6-day washout between treatments, during a stay at the clinic of 20 days
Sequence CBA	Experimental	Drug: Treatment A - 400 mg Fasting, Drug: Treatment B - 400 mg Fed, Drug: Treatment C - 200 mg FedHealthy volunteers will receive Treatments C, then B, and then A, with a 6-day washout between treatments, during a stay at the clinic of 20 days

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Is healthy at screening visit
Is not pregnant or lactating
Is surgically or naturally unable to reproduce, or agrees to remain sexually abstinent or to use double barrier methods of contraception from check-in until 90 days after the final dose of pexidartinib
Has a Body Mass Index (BMI) of 18-30 kg/m^2, inclusive
Has negative test results for protocol-defined drugs and diseases at screening and/or check-in

Key exclusion criteria (5 listed)

Per protocol or in the opinion of the investigator at screening and/or check-in, has something that would preclude participation:
Is an employee of the clinic or their family member

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
Treatment A - 400 mg FastingAlso: PexidartinibSingle oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
Treatment B - 400 mg FedAlso: PexidartinibSingle oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
Treatment C - 200 mg FedAlso: PexidartinibSingle oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA

Primary outcome

Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose
Mean Cmax of pexidartinib is calculated for each treatment period
Time to Cmax (Tmax)
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose
Median Tmax of pexidartinib is calculated for each treatment period
Area Under the Concentration-time Curve From Time of Dosing to Last Measurable Concentration (AUClast) and to Infinity (AUCinf)
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose
Mean AUClast and AUCinf for pexidartinib are calculated for each treatment period
Terminal Half-life (t1/2)
Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose
Mean t1/2 for pexidartinib is calculated for each treatment period

Results and safety

Results posted to the registry on 22 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence ABC	4	4
Sequence ACB	4	4
Sequence BAC	4	4
Sequence BCA	4	4
Sequence CAB	4	4
Sequence CBA	4	4

Primary outcome: Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib

Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A n = 24	Treatment B n = 24	Treatment C n = 24
Value	4580 (1240)	7090 (1590)	3870 (729)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: Time to Cmax (Tmax)

Time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose. Median (Full Range). Unit: hours

Measure	Treatment A n = 24	Treatment B n = 24	Treatment C n = 24
Value	2.00 (1.00 to 3.52)	3.50 (2.50 to 10.00)	3.30 (2.50 to 4.50)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: Area Under the Concentration-time Curve From Time of Dosing to Last Measurable Concentration (AUClast) and to Infinity (AUCinf)

Measure	Treatment A n = 24	Treatment B n = 24	Treatment C n = 24
AUClast	64800 (19300)	102000 (26300)	53600 (14200)
AUCinf	66100 (19900)	104000 (27400)	54600 (15000)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Primary outcome: Terminal Half-life (t1/2)

Measure	Treatment A n = 24	Treatment B n = 24	Treatment C n = 24
Value	24.2 (5.28)	23.1 (4.68)	23.6 (5.04)

Population analysed: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.

Adverse events

Time frame: Adverse events were collected from study enrollment up to 28 days of administration of the last dose of study treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24
Treatment B	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Treatment C	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

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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.

Global Clinical Leader study director

Daiichi Sankyo

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 Treatment A - 400 mg Fasting, Treatment B - 400 mg Fed and Treatment C - 200 mg Fed in people with Healthy Volunteers, run by Daiichi Sankyo 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 8 inclusion and 5 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 11 May 2020. 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 22 Apr 2020). 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?

Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib (time frame: Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and 144 hours postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03901313.

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 11 May 2020; AzTrials last refreshed its copy on 8 Nov 2026.