Pharmacokinetic Comparison of XS003 and Tasigna

Phase 1CompletedNCT02068898

XSpray Microparticles27 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

XS003DRUG

TasignaDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Quotient Clinical

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Bioavailability of Nilotinib

Pharmacokinetics measured by Area Under the Curve (AUC)

Time frame: 3 days

Data from ClinicalTrials.gov

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