COPDPhase 1NCT01817855

To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients

A Phase 1 study testing AZD7624 in people with COPD and Healthy Subjects, 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

This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic obstructive pulmonary disease. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: COPD, Healthy Subjects
What is being tested?: AZD7624
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2013to Oct 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
Provision of signed and dated, written informed consent prior to any study specific procedures
Plasma myoglobin and CK not above the upper reference range of the analysing laboratory at Day -1
Male and/or female patients with COPD aged above18 years with suitable veins for cannulation or repeated venipuncture.
Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines

Who cannot join

Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP
Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment within at least 3 months of the first administration of the IP in this study
Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator
Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
London

Other trials in United Kingdom

About this study

Official title: A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Patients With COPD

Read the detailed description

A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Patients with COPD

Conditions: COPD, Healthy Subjects
Being tested: AZD7624, Placebo to match
Keywords: Phase 1,, Safety,, Tolerability,, Healthy,, COPD patients
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

AZD7624Drug
Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer
Placebo to matchDrug
Multiple doses inhaled placebo via a nebulizer

Study groups in NCT01817855
Study group	Role	What they receive
1	Experimental	Groups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo. Receives: Drug: AZD7624
2	Placebo comparator	Groups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo. Receives: Drug: Placebo to match

What is being measured

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

Adverse Events
Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)
Measured: Up to 24 days

Secondary outcomes (3)

Summary of Pharmacokinetic Parameters (AUC(0-tau) )
Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9.
*AUC(0-tau) = AUC(0-last) where for cohorts 2,3,4,5 and 6 tau=24 hours and for cohort 1, tau=12 hours .
Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).
Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken.
Measured: PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.
Summary of Pharmacokinetic Parameters (Cmax)
Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).
Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken.
Measured: PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.
Summary of Pharmacokinetic Parameters (Cmin)
Summary of pharmacokinetic parameters of AZD7624 after multiple once daily dose administration in cohorts 4,5,6 and multiple twice daily administration in cohorts 1,2 and 3, on Days 7, 8 or 9. Results are presented for cohort 1,2,3,4,5 with SPIRA device and for cohort 6 with ADI device (test device).
Number of Participants Analyzed is based on the available data for the used device and for the day that PK measurements were taken.
Measured: PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.

Timeline

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

Sep 2013Oct 2014

First posted26 Mar 2013 (estimated)
Study startSep 2013
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies 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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01817855
Sponsor's protocol ID: D2550C00002
Status last verified: Feb 2016
First submitted: 18 Mar 2013
Last updated: 30 Mar 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, DoubleBlind Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Inhaled Doses (MAD) of AZD7624 to Healthy Subjects and Patients With COPD
ClinicalTrials.gov ID: NCT01817855
Acronym / sponsor ID: D2550C00002
Conditions: COPD, Healthy Subjects
Keywords: Phase 1,, Safety,, Tolerability,, Healthy,, COPD patients
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 26 Mar 2013 (estimated)
Results: Posted 30 Mar 2016

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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: AZD7624Groups 1-4 multiple ascending doses of AZD7624 Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 patients will receive matching placebo.
2	Placebo comparator	Drug: Placebo to matchGroups 1-4 multiple ascending doses of placebo Healthy subjects will participate in groups 1-3. In each group 6 subjects will receive AZD7624 and 2 will receive matching placebo. COPD patients will participate in group 4. In this group, 8 patients will receive AZD7624 and 2 will receive matching placebo.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
Provision of signed and dated, written informed consent prior to any study specific procedures
Plasma myoglobin and CK not above the upper reference range of the analysing laboratory at Day -1
Male and/or female patients with COPD aged above18 years with suitable veins for cannulation or repeated venipuncture.
Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines

Key exclusion criteria (5 listed)

Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP
Receipt of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment within at least 3 months of the first administration of the IP in this study
Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator
Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

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
AZD7624Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer	Drug	1
Placebo to matchMultiple doses inhaled placebo via a nebulizer	Drug	2

Primary outcome

Adverse Events
Time frame: Up to 24 days
Summary of number of subjects who had at least one adverse event in any category (Safety analysis set)

3 secondary outcomes

Summary of Pharmacokinetic Parameters (AUC(0-tau) )
Time frame: PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.
Summary of Pharmacokinetic Parameters (Cmax)
Time frame: PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.
Summary of Pharmacokinetic Parameters (Cmin)
Time frame: PK concentration was measured at 0, 15min, 30min, 45min, 1hr, 2hr, 4hr, 6hr, 9hr, 12hr, 18hr and 24hr post dose on Day 7 for cohort 6, Day 8 for cohorts 1,4 and 5 and on Day 9 for cohorts 2 and 3.

Results and safety

Results posted to the registry on 30 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD7624 Healthy Volunteers	23	23
Placebo Healthy Volunteers	8	6
AZD7624 COPD	11	9
Placebo COPD	5	5

Primary outcome: Adverse Events

Time frame: Up to 24 days. Number. Unit: Participants

Measure	AZD7624 Healthy Volunteers n = 23	Placebo Healthy Volunteers n = 8	AZD7624 COPD n = 11	Placebo COPD n = 5
Any Adverse Event (AE)	6	3	7	2
Any AE with outcome = death	0	0	0	0
Any SAE (including events with outcome = death)	0	0	0	0
Any AE leading to discontinuation	0	1	2	0

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 24 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD7624 Healthy Volunteers	0 of 23 (0%)	6 of 23 (26.1%)	Not reported
Placebo Healthy Volunteers	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
AZD7624 COPD	0 of 11 (0%)	7 of 11 (63.6%)	Not reported
Placebo COPD	0 of 5 (0%)	2 of 5 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
CSR SynopsisLink provided by the sponsor.

Related trials for COPD

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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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.

Saeed Khan, MBBS, MRCP principal investigator

Quintiles Drg Research Centre At Guys Hosipital, 6 Newcomen Street London SE1 1YR

Naimish Patel, MD study chair

AstraZeneca, Wilmington, US

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 AZD7624 in people with COPD and Healthy Subjects, 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 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 30 Mar 2016. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 30 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adverse Events (time frame: Up to 24 days). 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 NCT01817855.

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 30 Mar 2016.