Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT01754844
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects
A Phase 1 study testing AZD7624 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- AZD7624
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Aug 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects aged 18 to 55 years
- Able to inhale from the SPIRA nebuliser according to the provided instructions
- Females must have a negative pregnancy test at screening and on admission (Day 1) to the CPU, must not be lactating and must be of non-childbearing potential.
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg inclusive.
- FEV1 >80% of the predicted normal value.
Who cannot join
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History or family history of muscle diseases
- Known or suspected history of drug abuse as judged by the Investigator
- Use of any prescribed or non-prescribed medication including antacids, analgesics other than paracetamol/acetaminophen, herbal remedies, vitamins (excluding routine vitamins but including megadose [intake of 20 to 600 times the recommended daily dose])
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Placebo-controlled, Randomised, Single Centre, First Time in Man Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects
This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug) and pharmacodynamic (what the drug does to the body) parameters will be also assessed as secondary objectives.
Read the detailed description
A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects
- Being tested
- AZD7624, Placebo to match
- Keywords
- Phase 1, Healthy Volunteers, Single Ascending Dose (SAD), First Time in Man, Pharmacokinetics, Pharmacodynamics
- 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
Single dose inhaled IMP via a nebulizer
Placebo to matchDrug
Single dose inhaled Placebo via a nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Group 1-5, single ascending dose AZD7624 | Experimental | Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo. Receives: Drug: AZD7624 |
| Placebo | Placebo comparator | Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects 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.
Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)
Measured: up to 55 days.
Secondary outcomes (2)
Pharmacokinetics of AZD7624 and assess dose proportionality of the pharmacokinetics following single ascending doses of AZD7624 by assessment of Cmax, t1/2, AUC and CL/F.
Measured: Day 1 pre-dose, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 9h,12h, 18h, 24h, 36h, 48h, 56h post dose
Pharmacokinetics of single doses of AZD7624 using the following urine PK parameters: Ae and CLR
Measured: Day 1: during 0-6, 6-12, 12-24 and 24-48 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Lindgren, MD, Study director, AstraZeneca Research and Development SE-431 83 Molndal SwedenDarren G Wilbraham, Principal investigator, Quintiles Drug Research Unit at Guy's Hospital 6 Newcomen St London SE1 1YR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754844
- Sponsor's protocol ID
- D2550C00001
- Status last verified
- Apr 2015
- First submitted
- 19 Dec 2012
- Last updated
- 2 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled, Randomised, Single Centre, First Time in Man Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01754844
- Acronym / sponsor ID
- D2550C00001
- Keywords
- Phase 1, Healthy Volunteers, Single Ascending Dose (SAD), First Time in Man, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Dec 2012 (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.
This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug) and pharmacodynamic (what the drug does to the body) parameters will be also assessed as secondary objectives.
Detailed description
A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1-5, single ascending dose AZD7624 | Experimental | Drug: AZD7624Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo. |
| Placebo | Placebo comparator | Drug: Placebo to matchSubjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects 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
- Able to inhale from the SPIRA nebuliser according to the provided instructions
- Females must have a negative pregnancy test at screening and on admission (Day 1) to the CPU, must not be lactating and must be of non-childbearing potential.
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg inclusive.
- FEV1 >80% of the predicted normal value.
Key exclusion criteria (5 listed)
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History or family history of muscle diseases
- Known or suspected history of drug abuse as judged by the Investigator
- Use of any prescribed or non-prescribed medication including antacids, analgesics other than paracetamol/acetaminophen, herbal remedies, vitamins (excluding routine vitamins but including megadose [intake of 20 to 600 times the recommended daily dose])
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 |
|---|---|---|
| AZD7624Single dose inhaled IMP via a nebulizer | Drug | Group 1-5, single ascending dose AZD7624 |
| Placebo to matchSingle dose inhaled Placebo via a nebulizer | Drug | Placebo |
Primary outcome
Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry)
Time frame: up to 55 days.
2 secondary outcomes
Pharmacokinetics of AZD7624 and assess dose proportionality of the pharmacokinetics following single ascending doses of AZD7624 by assessment of Cmax, t1/2, AUC and CL/F.
Time frame: Day 1 pre-dose, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 9h,12h, 18h, 24h, 36h, 48h, 56h post dose
Pharmacokinetics of single doses of AZD7624 using the following urine PK parameters: Ae and CLR
Time frame: Day 1: during 0-6, 6-12, 12-24 and 24-48 hours post dose.
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 2 Apr 2015.
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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.
Sam Lindgren, MD study director
AstraZeneca Research and Development SE-431 83 Molndal Sweden
Darren G Wilbraham principal investigator
Quintiles Drug Research Unit at Guy's Hospital 6 Newcomen St London SE1 1YR
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 Chronic Obstructive Pulmonary Disease (COPD), 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 2 Apr 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. 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?
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?
Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry) (time frame: up to 55 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 2 Apr 2015.