Pharmacokinetic Comparison of XS003 and Tasigna

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: XS003; Drug: Tasigna

• Registration Number: NCT02068898
• Lead Sponsor: XSpray Microparticles

Brief 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.

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-21
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-10
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
XS003 Dose-level 2	XS003	Capsule formulation
XS003 Dose-level 3	XS003	Capsule formulation
Tasigna	Tasigna	Marketed capsule
XS003 Dose-level 1	XS003	Capsule formulation

Primary Outcome Measures

Name	Time	Method
Bioavailability of Nilotinib	3 days	Pharmacokinetics measured by Area Under the Curve (AUC)

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom