Chemokine Receptor 2 (CXCR2) AntagonistPhase 1NCT01480739

AZD5069 Neutrophil Function Study

A Phase 1 study testing 100 mg (50 mg x 2) AZD5069 in people with Chemokine Receptor 2 (CXCR2) Antagonist, run by AstraZeneca at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study in healthy volunteer to see effect of AZD5069 and placebo on neutrophil number and function (phagocytosis and oxidative burst) in the circulation, following a burst of strenuous exercise and following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF) Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Chemokine Receptor 2 (CXCR2) Antagonist
What is being tested?: 100 mg (50 mg x 2) AZD5069
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2011to Jul 2012
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Caucasian male or post-menopausal/surgical sterile females, aged 18 to 45 years inclusive at screening
Only women of non-childbearing potential are included in the study, ie, women who are permanently or surgically sterilised or post-menopausal
Non-smokers or ex-smokers with no smoking history the last 12 months prior to Visit 1 and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening
Body mass index (BMI) >18 kg/m2 and ≤30 kg/m2 and a minimum weight of 50 kg

Who cannot join

Subjects with a history of or active or latent tuberculosis (TB), or close contact with anybody with active TB
Subjects with a history of malignancy or neoplastic disease (except successfully treated basal or squamous cell carcinoma of the skin)
Subjects who are pyrexial with a body temperature of greater than 37.7 C at Visit 2, or as judged by the Investigator
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≥1.5 x upper limit of normal (ULN) at screening (Visit 2)
Peripheral blood neutrophils above or below the laboratory reference range at screening (Visit 2) hsCRP above the upper limit of the laboratory reference range at Visit 2

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
London, UK

Other trials in United Kingdom

About this study

Official title: A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils Into the Circulation After Exercise and Subcutaneous

Read the detailed description

A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils into the Circulation after Exercise and Subcutaneous

Conditions: Chemokine Receptor 2 (CXCR2) Antagonist
Being tested: 100 mg (50 mg x 2) AZD5069, 100 mg Placebo
Keywords: Phase 1, AZD5069, safety and tolerability, healthy volunteer,

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

100 mg (50 mg x 2) AZD5069Drug
Twice daily for 7 days
100 mg PlaceboDrug
Twice daily for 7 days

Study groups in NCT01480739
Study group	Role	What they receive
1	Experimental	AZD5069 100 mg capsules (50 mg BD) for 7 days Receives: Drug: 100 mg (50 mg x 2) AZD5069
2	Experimental	Placebo twice daily for 7 days Receives: Drug: 100 mg Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in status of Neutrophil function (phagocytosis and oxidative burst) in subjects on AZD5069 and placebo
Measured: Day -1, Day 1, Day 2, Day 3, Day 4 and 7 days after end of treatment.
Circulating neutrophils during exercise challenge measured by average neutrophil values over time
Measured: Pre-dose, 10 min, 2h, 4 hours post exercise test
Circulating neutrophils following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF)
Measured: Pre-dose, 2h, 6h, 12h, 24h, 36 hours post subcutaneous G-CSF

Secondary outcomes (4)

Adverse events
Measured: Screening to Day 63
Steady state 24 hour pharmacokinetic profile of the AZD5069 capsule following twice daily (bid) dosing
Measured: Pre-dose on Days 1 - 4 On Day 3 with sampling pre-dose and at 1h, 2h, 3h, 5h, 8h, and 12 hours post dose
Steady state 24 hour profile of circulating neutrophils following twice daily dosing of AZD5069 and its relationship to plasma concentration
Measured: Pre-dose and 1, 2, 3, 5, 8, 12 hours post each dose on Days 1 - 4, Day 6 and Day 7
Changes in baseline of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs, and physical examination findings will be presented
Measured: Screening to Day 63

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jul 2012

First posted29 Nov 2011 (estimated)
Study startDec 2011
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chemokine Receptor 2 (CXCR2) AntagonistStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01480739
Sponsor's protocol ID: D3550C00017
Status last verified: Jun 2015
First submitted: 24 Nov 2011
Last updated: 25 Jun 2015
Results posted: No

Publications

Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.
PubMed 29856004

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils Into the Circulation After Exercise and Subcutaneous
ClinicalTrials.gov ID: NCT01480739
Acronym / sponsor ID: D3550C00017
Conditions: Chemokine Receptor 2 (CXCR2) Antagonist
Keywords: Phase 1, AZD5069, safety and tolerability, healthy volunteer,
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 29 Nov 2011 (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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: 100 mg (50 mg x 2) AZD5069AZD5069 100 mg capsules (50 mg BD) for 7 days
2	Experimental	Drug: 100 mg PlaceboPlacebo twice daily for 7 days

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy Caucasian male or post-menopausal/surgical sterile females, aged 18 to 45 years inclusive at screening
Only women of non-childbearing potential are included in the study, ie, women who are permanently or surgically sterilised or post-menopausal
Non-smokers or ex-smokers with no smoking history the last 12 months prior to Visit 1 and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening
Body mass index (BMI) >18 kg/m2 and ≤30 kg/m2 and a minimum weight of 50 kg

Key exclusion criteria (5 listed)

Subjects with a history of or active or latent tuberculosis (TB), or close contact with anybody with active TB
Subjects with a history of malignancy or neoplastic disease (except successfully treated basal or squamous cell carcinoma of the skin)
Subjects who are pyrexial with a body temperature of greater than 37.7 C at Visit 2, or as judged by the Investigator
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) level ≥1.5 x upper limit of normal (ULN) at screening (Visit 2)
Peripheral blood neutrophils above or below the laboratory reference range at screening (Visit 2) hsCRP above the upper limit of the laboratory reference range at Visit 2

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
100 mg (50 mg x 2) AZD5069Twice daily for 7 days	Drug	1
100 mg PlaceboTwice daily for 7 days	Drug	2

Primary outcome

Change in status of Neutrophil function (phagocytosis and oxidative burst) in subjects on AZD5069 and placebo
Time frame: Day -1, Day 1, Day 2, Day 3, Day 4 and 7 days after end of treatment.
Circulating neutrophils during exercise challenge measured by average neutrophil values over time
Time frame: Pre-dose, 10 min, 2h, 4 hours post exercise test
Circulating neutrophils following subcutaneous injection of granulocyte-colony stimulating factor (G-CSF)
Time frame: Pre-dose, 2h, 6h, 12h, 24h, 36 hours post subcutaneous G-CSF

4 secondary outcomes

Adverse events
Time frame: Screening to Day 63
Steady state 24 hour pharmacokinetic profile of the AZD5069 capsule following twice daily (bid) dosing
Time frame: Pre-dose on Days 1 - 4 On Day 3 with sampling pre-dose and at 1h, 2h, 3h, 5h, 8h, and 12 hours post dose
Steady state 24 hour profile of circulating neutrophils following twice daily dosing of AZD5069 and its relationship to plasma concentration
Time frame: Pre-dose and 1, 2, 3, 5, 8, 12 hours post each dose on Days 1 - 4, Day 6 and Day 7
Changes in baseline of vital signs (blood pressure and pulse), clinical laboratory tests, ECGs, and physical examination findings will be presented
Time frame: Screening to Day 63

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 25 Jun 2015.
Derived from this study: PubMed 29856004Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.
CSR SynopsisLink provided by the sponsor.

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.

Tim Mant, MD principal investigator

Quintiles research Unit

Bengt Larsson, MD study director

AstraZeneca Medical Science Director

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 100 mg (50 mg x 2) AZD5069 in people with Chemokine Receptor 2 (CXCR2) Antagonist, run by AstraZeneca 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 25 Jun 2015. 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?

Change in status of Neutrophil function (phagocytosis and oxidative burst) in subjects on AZD5069 and placebo (time frame: Day -1, Day 1, Day 2, Day 3, Day 4 and 7 days after end of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01480739, which also lists 1 linked publication.

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 25 Jun 2015.