NCT01100047

Brief Summary

This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple doses up to 11 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2010

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
23 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

9 months

First QC Date

March 24, 2010

Last Update Submit

June 24, 2015

Conditions

Healthy

Keywords

Phase IJapanese healthy volunteerAZD5069

Outcome Measures

Primary Outcomes (1)

  • Adverse events, electrocardiograms (ECGs), laboratory variables, blood pressure, pulse rate, body temperature, QT interval and continuous cardiac monitoring using telemetry

    From screening period to follow-up visit 42 days (Maximum)

Secondary Outcomes (3)

  • Assessment of ex vivo GROa stimulated CD11b expression on neutrophils in whole blood

    Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose

  • Measurement of the effect of AZD5069 on blood cells

    Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose

  • Pharmacokinetic profile: concentration of AZD5069 in blood

    Baselines at Visit 1 or pre-dose Day 1, assessments Visit 2, post-dose until 96hr post final dose. Follow up assessments at Visit 3. Samples collected at Visit 2 from pre-dose and at regular protocol defined intervals up to 96 hours post-dose.

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD5069

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD5069DRUG

Oral suspension

1
PlaceboDRUG

Oral suspension

2

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Japanese subjects with suitable veins for cannulation or repeated venepuncture.
  • Have a body mass index (BMI) between 17 and 27 kg/m2 and a body weight between 45 and 80 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/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product.
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Croydon, United Kingdom

Location

Related Publications (1)

  • Cullberg M, Arfvidsson C, Larsson B, Malmgren A, Mitchell P, Wahlby Hamren U, Wray H. Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers. Drugs R D. 2018 Jun;18(2):149-159. doi: 10.1007/s40268-018-0236-x.

    PMID: 29856004DERIVED

Related Links

MeSH Terms

Interventions

N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide

Study Officials

  • Ulrike Lorch, Lorch, MD MFPM FRCA

    Richmond Pharmacology Limited

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 24, 2010

First Posted

April 8, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

GB(1)