Safety, Pharmacokinetics and Pharmacodynamics After Single and Multiple Dosing of AZD5423 in Japanese Healthy Male Subjects

NCT01338350 | Completed Phase 1

• 1 other identifier: D2340C00003
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours urine cortisol) of AZD5423 following administration of single and multiple ascending doses in healthy male Japanese subjects.

Conditions

Healthy

Keywords

safety; tolerability; pharmacokinetics; pharmacodynamics; AZD5423; Japanese

Outcome Measures

Primary Outcomes (1)

• To investigate the safety and tolerability (AE, blood pressure, pulse, ECG, Body temp, Haematology, Clin Chemistry, Urinalysis, phys exam, lung function) of AZD5423 following administration of single and multiple ascending doses.

  10-14 days after last dose

Secondary Outcomes (2)

• To characterise the single and multiple dose pharmacokinetics of AZD5423, and assess the dose proportionality, the time required to reach steady state and the degree of accumulation.

  72 hours after last dose

• To investigate the pharmacodynamic effects (24-hours plasma cortisol AUC, plasma cortisol pre and post ACTH stimulation, DHEAS, osteocalcin and 24 hours urine cortisol) of AZD5423 following administration of single and multiple ascending doses.

  10-14 days after last dose

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD5423

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD5423 DRUG

Inhalation, suspension

1

Placebo DRUG

Inhalation, solution

2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy male Japanese subjects aged 20 to 45 years with suitable veins for cannulation or repeated venepuncture
• Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after the last dose of investigational product
• Have a body mass index (BMI) between 18 and 27 kg/m2 and weight at least 50 kg and no more than 80 kg
• Be able to inhale from the I-nebⓇ according to given instruction

You may not qualify if:

• History of any clinically significant 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 presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product
• Any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigators
• Any positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) and Syphilis

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, Japan

Location

Related Links

• CSR Synopsis

MeSH Terms

Interventions

2,2,2-trifluoro-N-(1-((1-(4-fluorophenyl)-1H-indazol-5-yl)oxy)-1-(3-methoxyphenyl)-2-propanyl)acetamide

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 19, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

JP (1)