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

NCT ID: NCT00785668

Last Updated: 2008-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-02-29

Brief 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. 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.

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

Keywords

Asthma; Allergy; Interleukin-4; Interleukin-13; IL-4; IL-13; Pharmacokinetics; Safety; Tolerability; Aerovance; dry powder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Interventions

AER 001

10 mg dry powder administered using a handheld device

Intervention Type: DRUG

Other Intervention Names

AEROVANT, BAY 16-9996, Pitrakinra

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

• 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.

(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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aerovance, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Aerovance Inc.

Principal Investigators

Darren Wilbraham, MBBS, DCPSA

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

London, England, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 19717725 (View on PubMed)

Other Identifiers

QGUY/2007/AER 001/-04

Identifier Type: -

Identifier Source: org_study_id