AzTrials
AzTrials

AsthmaPhase 1NCT00785668

A Phase 1 Safety and Pharmacokinetics Study of AER 001 Administered as a Dry Powder in Asthmatic Subjects

A Phase 1 study testing AER 001 in people with Asthma, run by Aerovance, Inc. 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
Search all trials

Trial summary

This is a single centre, single dose pharmacokinetic/safety study in male and female asthmatic subjects. Subjects will receive a single dose of 10 mg of AER 001 administered as a dry powder using a handheld device. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
AER 001
How many people
10 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2007to Feb 2008
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult males and females > 18 years.
  • Subjects who if female, are not currently pregnant or breast feeding and are using medically acceptable methods of contraception and if male, are themselves and their female partners using medically acceptable methods of contraception.
  • Subjects who have a pre study medical history, physical examination, 12 Lead ECG acceptable to the investigator.
  • Subjects who have clinical laboratory tests within the reference ranges or clinically acceptable to the investigator.
  • Subjects who are negative for HbsAg, hepatitis C antibody and HIV II and I test at screening.
  • Subjects who are negative for drugs of abuse at screening and admission.
Show all 16Show fewer
  • Subjects who are negative for alcohol on admission.
  • Subjects who have an improvement in FEV1 of >10% following 400 ug salbutamol administration using a spacer device.
  • Subjects who have a FEV1 > 70% of predicted at screening and pre dose.
  • Subjects who have not received steroid treatment in the prior week.
  • Subjects who are non-smokers for at least 3 months prior to screening.
  • Subjects who have a < 10 pack year smoking history.
  • Subjects who satisfy the Global Initiative in Asthma (GINA, 2002) definition of asthma or have been on treatment for asthma.
  • Subjects who have a FEV 1 /FVC ratio >0.65 at screening and pre-dose.
  • Subjects with stable, adequately treated medical conditions may be enrolled provided the Principal Investigator does not consider their study participation to place them at increased risk of adverse events. Subjects should continue their concomitant treatments without change during the study.
  • Subjects who are able and willing to give written informed consent.

Who cannot join

  • Subjects who do not conform to the above inclusion criteria.
  • Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders which would preclude participation.
  • Subjects who have a history of relevant drug hypersensitivity.
  • Subjects who have a history of alcoholism.
  • Subjects who have a history of drug abuse.
  • Subjects who consume more than 28 units (male)/ 21 units (female) of alcohol a week.
Show all 16Show fewer
  • (unit = 1 glass of wine = 1 measure of spirits = ½ pint of beer)
  • Subjects who have acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn)
  • Subjects who have an acute respiratory infection such as influenza at the time of screening and/or admission.
  • Female subjects who are pregnant, breast feeding, or not using an acceptable method of contraception. Male subjects whoare not using an acceptable method of contraception or have a partner of child-bearing potential who is not using an acceptable method of contraception.
  • Subjects who have used any investigational drug and /or participated in any clinical trial within 3 months of their first dosing.
  • Subjects using medication, which in the opinion of the Investigator will affect the outcome of the study.
  • Subjects who have donated and/or received any blood or blood products within the previous 3 months prior to first dosing (to review on a case by case basis).
  • Subjects who cannot communicate reliably with the investigator.
  • Subjects who are unlikely to co-operate with the requirements of the study.
  • Subjects who have previously taken AER 001.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Guy's Drug Research Unit a division of Quintiles Ltd.

    London, England, SE1 1YR

Other trials in United Kingdom

About this study

This is a single centre, single dose pharmacokinetic/safety study in male and female asthmatic subjects. Subjects will receive a single dose of 10 mg of AER 001 administered as a dry powder using a handheld device. The goals of this study are to understand the pharmacokinetics and safety of AER 001 administered as a dry powder in mild to moderate asthmatics.

Read the detailed description

Study Design

  • Single centre, single dose PK/safety study in male and female asthmatic subjects.
  • Approximately 10 subjects will be dosed.
  • Treatments will be administered by dry powder inhalation using a handheld device
  • Subjects will attend the Unit for screening and if eligible return to the Unit on the day of dosing (Day 1). Subjects will be required to stay overnight in the Unit and will be discharged on Day 2.
  • On study Day 1, subjects are to receive a single administration of AER 001. N.B. Screening will take place within 28 days prior to administration of AER 001.

Primary objective: To investigate the pharmacokinetics of AER 001 administered as a dry powder in mild to moderate asthmatics.

Secondary objective: To investigate the safety of AER 001 administered as a dry powder in mild to moderate asthmatics.

Conditions
Asthma
Being tested
AER 001
Keywords
Asthma, Allergy, Interleukin-4, Interleukin-13, IL-4, IL-13, Pharmacokinetics, Safety, Tolerability, Aerovance, dry powder
Medical subject headings
Asthma, Hypersensitivity, Rhinitis, Allergic

What participants receive

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

  • AER 001Drug

    Also called AEROVANT, BAY 16-9996, Pitrakinra

    10 mg dry powder administered using a handheld device

What is being measured

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

  1. The area under the plasma concentration-time curves will be the primary PK parameter. Maximum observed plasma drug concentrations, time of occurrence of Cmax, the apparent terminal rate constant and corresponding half-life will also be derived.

    Measured: 24 hours

Secondary outcomes (1)

  1. Safety evaluation will include lung function measurements, blood pressure, heart rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, urinalysis, urine and urine microscopy, if required) and adverse events.

    Measured: 24 hours

Timeline

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

  1. First posted5 Nov 2008 (estimated)
  2. Study startNov 2007
  3. Study completionFeb 2008

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00785668
Sponsor's protocol ID
QGUY/2007/AER 001/-04
Status last verified
Nov 2008
First submitted
3 Nov 2008
Last updated
5 Nov 2008
Results posted
No
Data monitoring committee
No

Publications

  • Burmeister Getz E, Fisher DM, Fuller R. Human pharmacokinetics/pharmacodynamics of an interleukin-4 and interleukin-13 dual antagonist in asthma. J Clin Pharmacol. 2009 Sep;49(9):1025-36. doi: 10.1177/0091270009341183.

    PubMed 19717725

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AER 001 in people with Asthma, run by Aerovance, Inc. 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 16 inclusion and 16 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 5 Nov 2008. 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?

The area under the plasma concentration-time curves will be the primary PK parameter. Maximum observed plasma drug concentrations, time of occurrence of Cmax, the apparent terminal rate constant and corresponding half-life will also be derived. (time frame: 24 hours). 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 NCT00785668, 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 5 Nov 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in