AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects

NCT00970775 | Completed Phase 1

• 1 other identifier: D2600C00003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese subjects.

Conditions

Healthy Volunteer

Keywords

Phase I; Japanese healthy volunteer; AZD2423

Outcome Measures

Primary Outcomes (1)

• To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables.

  From screening period to follow-up visit, 40 days (Maximum).

Secondary Outcomes (2)

• To characterize the pharmacokinetics of AZD2423 in plasma and urine.

  Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately)

• Exploratory endpoints;Levels of CCL2 pre-and post dose

  Blood sampling after dosing, 3 days

Study Arms (2)

1. AZD2423

EXPERIMENTAL

Drug: AZD2423

2. Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD2423 DRUG

oral solution, single dose

1. AZD2423

Placebo DRUG

oral solution,single dose

2. Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture.
• Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2
• Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator.

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.
• Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.
• Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Croydon, United Kingdom

Location

Research Site

London, United Kingdom

Location

Study Officials

• Ulrike Lorch, MD MFPM FRCA

  Richmond Pharmacology Limited

  PRINCIPAL INVESTIGATOR

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: September 1, 2009
• First Posted: September 2, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 18, 2010

Record last verified: 2010-03

Locations

GB (2)