Chronic Obstructive Pulmonary DiseasePhase 1NCT01083238
This Study Will Investigate How Food and Age Effect the Way the Body Handles the AZD5069 Drug Given as a Oral Dose
A Phase 1 study testing AZD5069 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
AZD5069 is a new drug being tested for the possible treatment of people with chronic obstructive pulmonary disease (COPD). This is not the first time that AZD5069 will be administered to humans in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- AZD5069
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Jul 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
Who cannot join
- Has participated in another clinical study and received drug treatment within 3 months of the first administration of drug in this study.
- Subjects with a past medical history of tuberculosis (TB).
- Subjects with latent or chronic infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Two-part Study to Investigate the Effects of Food on the PK, Safety and Tolerability of a Single Oral Dose of AZD5069 (120 mg) in Healthy Adult Volunteers (Part A) and to Compare the PK of AZD5069 in Adult and Elderly Healthy Volunteers (Part B)
AZD5069 is a new drug being tested for the possible treatment of people with chronic obstructive pulmonary disease (COPD).
This is not the first time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females in fed and fasted states. We will compare the way the body handles this drug in the fed and fasted states, in subjects in the age group of 18 to 65 years. We will compare the way the body handles this drug between the age groups of 18 to 65 years and above 65 years. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- AZD5069
- Keywords
- pharmacokinetics, fasting or after a high fat meal, adult, elderly adult, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5069Drug
120mg single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD5069 following a 10-hour fast Receives: Drug: AZD5069 |
| 2 | Experimental | AZD5069 30 minutes after the start of a high fat meal Receives: Drug: AZD5069 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic blood to measure Maximum plasma concentration (Cmax); time to Cmax (tmax); and the area under the plasma concentration-time curve from zero to infinity (AUC).
Measured: 0 - 72 hours postdose
Secondary outcomes (1)
Safety and tolerability of AZD5069 by assessing Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables (including high sensitivity C-reactive protein [hsCRP] and circulating neutrophils), blood pressure, pulse rate, body temperature
Measured: various timepoints throughout the study from predose to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2010
- Study completionJul 2010
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 Chronic Obstructive Pulmonary DiseaseStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Darren Wilbraham, MBBS DCPSA, Principal investigator, Quintiles Drug Research Unit at Guy's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083238
- Sponsor's protocol ID
- D3550C00010
- Status last verified
- Jun 2015
- First submitted
- 22 Feb 2010
- 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
- A Phase I, Two-part Study to Investigate the Effects of Food on the PK, Safety and Tolerability of a Single Oral Dose of AZD5069 (120 mg) in Healthy Adult Volunteers (Part A) and to Compare the PK of AZD5069 in Adult and Elderly Healthy Volunteers (Part B)
- ClinicalTrials.gov ID
- NCT01083238
- Acronym / sponsor ID
- D3550C00010
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- pharmacokinetics, fasting or after a high fat meal, adult, elderly adult, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Feb 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 9 Mar 2010 (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.
AZD5069 is a new drug being tested for the possible treatment of people with chronic obstructive pulmonary disease (COPD).
This is not the first time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females in fed and fasted states. We will compare the way the body handles this drug in the fed and fasted states, in subjects in the age group of 18 to 65 years. We will compare the way the body handles this drug between the age groups of 18 to 65 years and above 65 years. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD5069AZD5069 following a 10-hour fast |
| 2 | Experimental | Drug: AZD5069AZD5069 30 minutes after the start of a high fat meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
Key exclusion criteria (3 listed)
- Has participated in another clinical study and received drug treatment within 3 months of the first administration of drug in this study.
- Subjects with a past medical history of tuberculosis (TB).
- Subjects with latent or chronic infections
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 |
|---|---|---|
| AZD5069120mg single oral dose | Drug | 1, 2 |
Primary outcome
Pharmacokinetic blood to measure Maximum plasma concentration (Cmax); time to Cmax (tmax); and the area under the plasma concentration-time curve from zero to infinity (AUC).
Time frame: 0 - 72 hours postdose
1 secondary outcome
Safety and tolerability of AZD5069 by assessing Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables (including high sensitivity C-reactive protein [hsCRP] and circulating neutrophils), blood pressure, pulse rate, body temperature
Time frame: various timepoints throughout the study from predose to follow-up
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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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.
Darren Wilbraham, MBBS DCPSA principal investigator
Quintiles Drug Research Unit at Guy's Hospital
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 AZD5069 in people with Chronic Obstructive Pulmonary Disease, 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 1 inclusion and 3 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?
Pharmacokinetic blood to measure Maximum plasma concentration (Cmax); time to Cmax (tmax); and the area under the plasma concentration-time curve from zero to infinity (AUC). (time frame: 0 - 72 hours postdose). 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 NCT01083238, 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.