Pharmacokinetic Comparison of XS003 and Tasigna

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02068898
• Other study ID #: XS003_CT001
• Status: Completed
• Phase: Phase 1
• First received: February 19, 2014
• Last updated: November 10, 2014
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: November 2014
• Source: XSpray Microparticles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• XS003

• Tasigna

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
XSpray Microparticles

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of Nilotinib	Pharmacokinetics measured by Area Under the Curve (AUC)	3 days	No