Pharmacokinetic Comparison of XS003 and Tasigna

A Comparative, Proof of Concept Study, Comprising of a Pilot Phase Bioavailability Study Part and a Randomised, Cross-over Food-effect Study Part of "XS003" and Originator in Healthy Male Subjects

The study will assess bioavailability of XS003 given as a single oral dose compared to Tasigna® given as a single oral dose in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Tasigna; Drug: XS003

Detailed Description

The study consists of two parts, the first part is composed as a pilot part and compares the bioavailability of single oral doses of XS003 compared to Tasigna® given as single oral dose in healthy male subjects. The second part is a food-effect part which assesses the food effect of a single oral dose of XS003 in healthy male subjects either fed or fasted. The study will also evaluate safety and tolerability of XS003 as secondary objectives.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy males
• Age 18 to 55 years of age
• Body mass index (BMI) of 18.0 to 29.0 kg/m2
• Laboratory parameters in normal range

Exclusion Criteria:

• Females
• Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening.
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
• History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator.
• Subject has a QTcF>450 ms based on ECG at screening or a history of additional risk factors for Torsades de Pointe (e.g. hypokalaemia, hypomagnesemia, a family history of long QT syndrome)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: XS003 Dose-level 1; Capsule formulation	Drug: XS003; Other Names: RightSize Nilotinib
EXPERIMENTAL: XS003 Dose-level 2; Capsule formulation	Drug: XS003; Other Names: RightSize Nilotinib
EXPERIMENTAL: XS003 Dose-level 3; Capsule formulation	Drug: XS003; Other Names: RightSize Nilotinib
EXPERIMENTAL: Tasigna; Marketed capsule	Drug: Tasigna; Other Names: Nilotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioavailability of Nilotinib	Pharmacokinetics measured by Area Under the Curve (AUC)	3 days

Collaborators and Investigators

• Sponsor: XSpray Microparticles
• Investigators: Study Director: XSpray Microparticles, XSpray Microparticles

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (ESTIMATE): February 21, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 11, 2014
• Last Update Submitted That Met QC Criteria: November 10, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: XS003_CT001