HealthyPhase 1NCT02068898
Pharmacokinetic Comparison of XS003 and Tasigna
A Phase 1 study testing XS003 and Tasigna in people with Healthy, run by XSpray Microparticles at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- XS003 and Tasigna
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to May 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- XS003, Tasigna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XS003Drug
Also called RightSize Nilotinib
TasignaDrug
Also called Nilotinib
| Study group | Role | What they receive |
|---|---|---|
| XS003 Dose-level 1 | Experimental | Capsule formulation Receives: Drug: XS003 |
| XS003 Dose-level 2 | Experimental | Capsule formulation Receives: Drug: XS003 |
| XS003 Dose-level 3 | Experimental | Capsule formulation Receives: Drug: XS003 |
| Tasigna | Experimental | Marketed capsule Receives: Drug: Tasigna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of Nilotinib
Pharmacokinetics measured by Area Under the Curve (AUC)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- XSpray Microparticles
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- XSpray Microparticles, Study director, XSpray Microparticles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068898
- Sponsor's protocol ID
- XS003_CT001
- Status last verified
- Nov 2014
- First submitted
- 19 Feb 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02068898
- Acronym / sponsor ID
- XS003_CT001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- XSpray MicroparticlesIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| XS003 Dose-level 1 | Experimental | Drug: XS003Capsule formulation |
| XS003 Dose-level 2 | Experimental | Drug: XS003Capsule formulation |
| XS003 Dose-level 3 | Experimental | Drug: XS003Capsule formulation |
| Tasigna | Experimental | Drug: TasignaMarketed capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XS003Also: RightSize Nilotinib | Drug | XS003 Dose-level 1, XS003 Dose-level 2, XS003 Dose-level 3 |
| TasignaAlso: Nilotinib | Drug | Tasigna |
Primary outcome
Bioavailability of Nilotinib
Time frame: 3 days
Pharmacokinetics measured by Area Under the Curve (AUC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XSpray Microparticles study director
XSpray Microparticles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XS003 and Tasigna in people with Healthy, run by XSpray Microparticles at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioavailability of Nilotinib (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.