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Pharmacokinetic Comparison of XS003 and Tasigna

NCT ID: NCT02068898

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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XS003 Dose-level 2

Capsule formulation

Group Type EXPERIMENTAL

XS003

Intervention Type DRUG

XS003 Dose-level 1

Capsule formulation

Group Type EXPERIMENTAL

XS003

Intervention Type DRUG

XS003 Dose-level 3

Capsule formulation

Group Type EXPERIMENTAL

XS003

Intervention Type DRUG

Tasigna

Marketed capsule

Group Type EXPERIMENTAL

Tasigna

Intervention Type DRUG

Interventions

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XS003

Intervention Type DRUG

Tasigna

Intervention Type DRUG

Other Intervention Names

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RightSize Nilotinib Nilotinib

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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XSpray Microparticles

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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XSpray Microparticles

Role: STUDY_DIRECTOR

XSpray Microparticles

Locations

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Quotient Clinical

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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XS003_CT001

Identifier Type: -

Identifier Source: org_study_id