NCT02068898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

3 months

First QC Date

February 19, 2014

Last Update Submit

November 10, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Bioavailability of Nilotinib

    Pharmacokinetics measured by Area Under the Curve (AUC)

    3 days

Study Arms (4)

XS003 Dose-level 1

EXPERIMENTAL

Capsule formulation

Drug: XS003

XS003 Dose-level 2

EXPERIMENTAL

Capsule formulation

Drug: XS003

XS003 Dose-level 3

EXPERIMENTAL

Capsule formulation

Drug: XS003

Tasigna

EXPERIMENTAL

Marketed capsule

Drug: Tasigna

Interventions

XS003DRUG
Also known as: RightSize Nilotinib
XS003 Dose-level 1XS003 Dose-level 2XS003 Dose-level 3
TasignaDRUG
Also known as: Nilotinib
Tasigna

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

nilotinib

Study Officials

  • XSpray Microparticles

    XSpray Microparticles

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

May 1, 2014

Last Updated

November 11, 2014

Record last verified: 2014-11

Locations

GB(1)