A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects

NCT01096563 | Terminated Phase 1

• 2 other identifiers: D1882C000042009-015560-34
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses in Japanese subjects.

Conditions

Healthy

Keywords

Phase I; Japanese healthy volunteer; AZD9164

Outcome Measures

Primary Outcomes (1)

• Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)

  Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Secondary Outcomes (2)

• To investigate the pharmacokinetics (PK) of AZD9164 following inhaled administration of single and multiple ascending doses, by assessment of the dose proportionality, the degree of accumulation and the time linearity

  PK sampling during the residential period and intense PK sampling on day 1 and day 15 (up to 72 and 120 hours respectively)

• To investigate pharmacodynamic (PD) effects of inhaled single and multiple ascending doses of AZD9164, by assessment of lung function

  Spirometry during the residential stay on days 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15

Study Arms (2)

1

EXPERIMENTAL

AZD9164

Drug: AZD9164

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD9164 DRUG

Dry powder for inhalation via Turbuhaler, JSMAD. A single dose of AZD9164 on Day 1 and repeated dosing on Day 4 to day 15 (JSMAD). The starting dose will be 400 μg delivered dose and subsequent doses are planned to be 1000 μg and 2800 μg delivered dose.

1

Placebo DRUG

Dry powder for inhalation via Turbuhaler, JSMAD.

2

Eligibility Criteria

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

You may qualify if:

• Healthy Japanese subjects with suitable veins for cannulation or repeated venipuncture
• Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg
• Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

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 absorption, distribution, metabolism or excretion of drugs
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Croydon, United Kingdom

Location

Related Publications (1)

• Jorup C, Bengtsson T, Strandgarden K, Sjobring U. Transient paradoxical bronchospasm associated with inhalation of the LAMA AZD9164: analysis of two Phase I, randomised, double-blind, placebo-controlled studies. BMC Pulm Med. 2014 Mar 27;14:52. doi: 10.1186/1471-2466-14-52.

  PMID: 24669829 DERIVED

MeSH Terms

Interventions

AZD9164

Study Officials

• Ulrike Lorch, MD MFPM FRCA

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

• Carin Jorup

  AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 31, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 3, 2010

Record last verified: 2010-12

Locations

GB (1)