Uncontrolled and Persistent AsthmaPhase 1NCT01989520
Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069
A Phase 1 study testing Phase IIb formulation, Putative phase III formulation and Slow dissolution variant 1 in people with Uncontrolled and Persistent Asthma, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
Study to investigate relative bioavailability of up to five different formulations of AZD5069 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Uncontrolled and Persistent Asthma
- What is being tested?
- Phase IIb formulation, Putative phase III formulation and Slow dissolution variant 1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Apr 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female volunteers aged 18 to 50 years (inclusive).
- Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening.
- Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) weight 50 kg and maximum (max) weight 100 kg.
- Healthy volunteers with neutrophil counts within the laboratory range at screening.
- -
Who cannot join
- A definite or suspected personal history of severe allergy, intolerance or hypersensitivity or ongoing allergy to drugs with a similar chemical structure or class to AZD5069 and/or the excipients, as judged to be clinically relevant by the Investigator.
- Healthy volunteers who have previously received AZD5069.
- Volunteers with latent tuberculosis as suggested by their history and judged by the Investigator; confirmatory testing with eg, Quantiferon(R) -TB Gold may be done if required.
- Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the IP -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers
Study to investigate relative bioavailability of up to five different formulations of AZD5069
Read the detailed description
An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers
- Conditions
- Uncontrolled and Persistent Asthma
- Being tested
- Phase IIb formulation, Putative phase III formulation, Slow dissolution variant 1, Slow dissolution variant 2, Test treatment E
- Keywords
- Relative bioavailability, Healthy volunteers, Neutrophils
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase IIb formulationDrug
Single oral dose 45mg AZD5069
Putative phase III formulationDrug
Single oral dose 45mg AZD5069
Slow dissolution variant 1Drug
Single oral dose 45mg AZD5069
Slow dissolution variant 2Drug
Single oral dose 45mg AZD 5069
Test treatment EDrug
Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Phase IIb formulation Receives: Drug: Phase IIb formulation |
| Treatment B | Experimental | Putative phase III formulation Receives: Drug: Putative phase III formulation |
| Treatment C | Experimental | Slow dissolution variant 1 Receives: Drug: Slow dissolution variant 1 |
| Treatment D | Experimental | Slow dissolution variant 2 Receives: Drug: Slow dissolution variant 2 |
| Treatment E | Experimental | Optional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069 Receives: Drug: Test treatment E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of pharmacokinetics of AZD5069 and its metabolite in terms of area under plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration and extrapolated to infinity (AUC(0-last) and AUC)
Curve taken during each of the 5 treatments
Measured: Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Description of pharmacokinetics of AZD5069 and its metabolite in terms of observed maximum plasma concentration (Cmax), plasma concentration measured at 12 hours (C12h), Cmax/C12h ratio, Cmax/AUC ratio, terminal rate constant (λz)
Curve taken during each of the 5 treatments
Measured: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax)
Curve taken during each of the 5 treatments
Measured: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Description of pharmacokinetics of AZD5069 and its metabolite in terms of apparent systemic clearance (CL/F) (AZD5069 only), and apparent volume of distribution (Vz/F) (AZD5069 only)
Curve taken during each of the 5 treatments
Measured: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Secondary outcomes (3)
Description of effect on neutrophils in terms of circulating neutrophil numbers reported as absolute circulating neutrophil counts (ANC). The minimum absolute neutrophil count (ANCmin) and the time to ANCmin (ANCtmin)
Samples taken during each of the 5 treatments
Measured: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Description of effect on neutrophils in terms of mean of ANC values from predose to 24 hours postdose (ANCmean), the minimum of the ANC ratio values (ANCmin,ratio)
Samples taken during each of the 5 treatments
Measured: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Description of effect on neutrophils in terms of the mean of ANC ratio values calculated baseline to 24 hours post dose (ANCmean,ratio)
Samples taken during each of the 5 treatments
Measured: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014
- Study completionApr 2014
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 Uncontrolled and Persistent AsthmaStudies 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olufeyikemi Oluwayi, MD, Principal investigator, Quintiles London UKBengt Larssons, MD, Study director, Astrazeneca Mölndal, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989520
- Sponsor's protocol ID
- D3551C00002
- Status last verified
- Jun 2015
- First submitted
- 15 Nov 2013
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- 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
- An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01989520
- Acronym / sponsor ID
- D3551C00002
- Conditions
- Uncontrolled and Persistent Asthma
- Keywords
- Relative bioavailability, Healthy volunteers, Neutrophils
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Nov 2013 (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.
Study to investigate relative bioavailability of up to five different formulations of AZD5069
Detailed description
An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Phase IIb formulationPhase IIb formulation |
| Treatment B | Experimental | Drug: Putative phase III formulationPutative phase III formulation |
| Treatment C | Experimental | Drug: Slow dissolution variant 1Slow dissolution variant 1 |
| Treatment D | Experimental | Drug: Slow dissolution variant 2Slow dissolution variant 2 |
| Treatment E | Experimental | Drug: Test treatment EOptional treatment that may use one of 3 45 mg (intermediate dissolution variant) of AZD5069 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and/or female volunteers aged 18 to 50 years (inclusive).
- Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening.
- Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum (min) weight 50 kg and maximum (max) weight 100 kg.
- Healthy volunteers with neutrophil counts within the laboratory range at screening.
- -
Key exclusion criteria (4 listed)
- A definite or suspected personal history of severe allergy, intolerance or hypersensitivity or ongoing allergy to drugs with a similar chemical structure or class to AZD5069 and/or the excipients, as judged to be clinically relevant by the Investigator.
- Healthy volunteers who have previously received AZD5069.
- Volunteers with latent tuberculosis as suggested by their history and judged by the Investigator; confirmatory testing with eg, Quantiferon(R) -TB Gold may be done if required.
- Volunteers who have received live or live-attenuated vaccine in the 2 weeks prior to the first administration of the IP -
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 |
|---|---|---|
| Phase IIb formulationSingle oral dose 45mg AZD5069 | Drug | Treatment A |
| Putative phase III formulationSingle oral dose 45mg AZD5069 | Drug | Treatment B |
| Slow dissolution variant 1Single oral dose 45mg AZD5069 | Drug | Treatment C |
| Slow dissolution variant 2Single oral dose 45mg AZD 5069 | Drug | Treatment D |
| Test treatment ETablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069 | Drug | Treatment E |
Primary outcome
Description of pharmacokinetics of AZD5069 and its metabolite in terms of area under plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration and extrapolated to infinity (AUC(0-last) and AUC)
Time frame: Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Curve taken during each of the 5 treatments
Description of pharmacokinetics of AZD5069 and its metabolite in terms of observed maximum plasma concentration (Cmax), plasma concentration measured at 12 hours (C12h), Cmax/C12h ratio, Cmax/AUC ratio, terminal rate constant (λz)
Time frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Curve taken during each of the 5 treatments
Description of pharmacokinetics of AZD5069 and its metabolite in terms of terminal half-life (t½λz), time to reach maximum plasma concentration (tmax)
Time frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Curve taken during each of the 5 treatments
Description of pharmacokinetics of AZD5069 and its metabolite in terms of apparent systemic clearance (CL/F) (AZD5069 only), and apparent volume of distribution (Vz/F) (AZD5069 only)
Time frame: Sample taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose
Curve taken during each of the 5 treatments
3 secondary outcomes
Description of effect on neutrophils in terms of circulating neutrophil numbers reported as absolute circulating neutrophil counts (ANC). The minimum absolute neutrophil count (ANCmin) and the time to ANCmin (ANCtmin)
Time frame: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Description of effect on neutrophils in terms of mean of ANC values from predose to 24 hours postdose (ANCmean), the minimum of the ANC ratio values (ANCmin,ratio)
Time frame: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
Description of effect on neutrophils in terms of the mean of ANC ratio values calculated baseline to 24 hours post dose (ANCmean,ratio)
Time frame: Baseline sample taken at predose day 1 and then 2, 4, 6, 8, 10, 12, and 24 hours postdose
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.
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RecruitingObservational study
Expression of TSLP Isoforms in Asthma
Asthma Atopic, Asthma Severe Persistent Uncontrolled
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.
Olufeyikemi Oluwayi, MD principal investigator
Quintiles London UK
Bengt Larssons, MD study director
Astrazeneca Mölndal, Sweden
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 Phase IIb formulation, Putative phase III formulation and Slow dissolution variant 1 in people with Uncontrolled and Persistent Asthma, 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 5 inclusion and 4 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?
Description of pharmacokinetics of AZD5069 and its metabolite in terms of area under plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration and extrapolated to infinity (AUC(0-last) and AUC) (time frame: Samples taken predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, and 24 hours postdose). The study lists 4 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 NCT01989520, 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.