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

NCT03901313 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PL3397-A-U128
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• Maximum Observed Concentration in Plasma (Cmax) of Pexidartinib

  Mean Cmax of pexidartinib is calculated for each treatment period

  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

  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

  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

  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

Study Arms (6)

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

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

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

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

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

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

Drug: Treatment A - 400 mg Fasting; Drug: Treatment B - 400 mg Fed; Drug: Treatment C - 200 mg Fed

Interventions

Treatment A - 400 mg Fasting DRUG

Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions

Also known as: Pexidartinib

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Treatment B - 400 mg Fed DRUG

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

Also known as: Pexidartinib

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Treatment C - 200 mg Fed DRUG

Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal

Also known as: Pexidartinib

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

pexidartinib

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sankyo, Inc.

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 3, 2019
• Study Start: April 1, 2019
• Primary Completion: May 8, 2019
• Study Completion: May 22, 2019
• Last Updated: May 11, 2020
• Results First Posted: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

US (1)