A Study in Healthy Subjects and Mild Asthmatics to Investigate Pharmacokinetics of AZD5423 When Administered in Different Ways

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Asthma; Healthy

Treatments: Drug: AZD5423

Study type: Interventional

Funder types: Industry

Identifiers

NCT01310322

D2340C00008

Details and patient eligibility

About

A study in healthy subjects and mild asthmatics to investigate Pharmacokinetics of AZD5423 when administered in different ways.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male healthy subjects and male asthma patients aged 18 to 45 years (inclusive)
• Have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive and rounding allowed) and weight between 50 and 100 kg (inclusive)
• Be able to inhale from the SPIRA nebuliser and I-neb® according to the provided instructions
• Asthma patients should fulfil the following criteria: Pre-bronchodilator forced expiratory volume at 1 second (FEV1) ≥70% of predicted normal value
• Asthma diagnosis according to GINA guidelines with a history of episodic wheeze and shortness of breath

Exclusion criteria

• History of any clinically significant disease or disorder
• Any clinically relevant abnormal findings
• Current smokers
• Asthma patients: Worsening of asthma or respiratory infection within 6 weeks before screening
• Asthma patients: Use of inhaled, nasal, oral, rectal or parenteral corticosteroids within 30 days before first administration of investigational product and during the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 4 patient groups

1

Experimental group

Description:

AZD5423 iv

Treatment:

Drug: AZD5423

Drug: AZD5423

Drug: AZD5423

Drug: AZD5423

2

Experimental group

Description:

AZD5423 inhalation, Spira

Treatment:

Drug: AZD5423

Drug: AZD5423

Drug: AZD5423

Drug: AZD5423

3

Experimental group

Description:

AZD5423 inhalation I-neb

Treatment:

Drug: AZD5423

Drug: AZD5423

Drug: AZD5423

Drug: AZD5423

4

Experimental group

Description:

AZD5423 oral

Treatment:

Drug: AZD5423

Drug: AZD5423

Drug: AZD5423

Drug: AZD5423