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Evaluating the Pharmacokinetic Parameters and Relative Bioavailability of Sorafenib (XS005) in Healthy Male Subjects

NCT05967377 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-08-01

No results posted yet for this study

Summary

This is a single centre, open-label, randomised, single dose, 3-way crossover comparative (PK) and bioavailability study in healthy male subjects comparing a 200 mg Sorafenib (Nexavar®) reference tablet (Regimen A) to XS005 Sorafenib Capsule A, 2 x 50 mg (Regimen B) and XS005 Sorafenib Tablet A,100 mg (Regimen C) formulation. It is planned to enroll 15 subjects who will receive single oral doses of investigational medicinal product (IMP) across 3 treatment periods.

Conditions

  • Pharmacokinetics
  • Bioavailability

Interventions

DRUG

Sorafenib - Period 1

Sorafenib (Nexavar®) Tablet, 200 mg

DRUG

XS005 Sorafenib Capsule A - Period 1

XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)

DRUG

XS005 Sorafenib Tablet A - Period 1

XS005 Sorafenib Tablet A, 100 mg

DRUG

XS005 Sorafenib Capsule A - Period 2

XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)

DRUG

XS005 Sorafenib Tablet A - Period 2

XS005 Sorafenib Tablet A, 100 mg

DRUG

Sorafenib - Period 2

Sorafenib (Nexavar®) Tablet, 200 mg

DRUG

XS005 Sorafenib Tablet A - Period 3

XS005 Sorafenib Tablet A, 100 mg

DRUG

Sorafenib - Period 3

Sorafenib (Nexavar®) Tablet, 200 mg

DRUG

XS005 Sorafenib Capsule A - Period 3

XS005 Sorafenib Capsule A, 100 mg (2 x 50 mg)

Sponsors & Collaborators

  • Xspray Pharma AB

    lead INDUSTRY

Principal Investigators

  • Sharan Sidhu, MBChB, BAO, MRCS, MFPM · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2019-02-12
Completion
2019-02-12

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05967377 on ClinicalTrials.gov