NCT00953888

Brief Summary

The purpose of this study is to determine how well tolerated and safe AZD5069 is at different dose levels in healthy male and/or females. The study will also investigate how quickly AZD5069 is absorbed into and cleared by the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
203

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jul 2009

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

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 25, 2015

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

August 5, 2009

Last Update Submit

June 24, 2015

Conditions

Healthy

Keywords

Healthy volunteerSingle ascending doseSafetyTolerabilityHealthy volunteer study

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of AZD5069 assessing vitals signs (blood pressure, pulse rate,body temperature), ECG,laboratory variables (including high sensitivity C-reactive protein, circulating neutrophils), continuous cardiac monitoring using telemetry.

    Baselines assessments at Visit 1 (enrolment). Assessments pre-dose at Visit 2 and at protocol defined time-points post-dose. Follow up assessments at Visit 3.

Secondary Outcomes (3)

  • Pharmacokinetic profile: concentration of AZD5069 in 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 circulating neutrophils

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

  • Pharmacodynamic profile: 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 48 hours post-dose.

Study Arms (2)

Active

EXPERIMENTAL

AZD5069 oral solution

Drug: AZD5069

Placebo

PLACEBO COMPARATOR

Placebo oral solution

Drug: Placebo

Interventions

AZD5069DRUG

Single dose of oral solution.

Active
PlaceboDRUG

Single dose of oral solution.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated, written informed consent
  • Healthy male or female (of non child bearing potential) caucasian subjects aged 18 to 65 years with suitable veins for cannulation or repeated venepuncture
  • Body mass index of between 18 and 30 kg/m2 inclusive

You may not qualify if:

  • Subjects must not have 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 subjects ability to participate in the study
  • Subjects must not have any history of gastrointestinal, liver or kidney disease, or any other condition known to interfere with how drugs are absorbed, used or eliminated by the body
  • Subjects must not have had any significant illness or medical/surgical procedures or injuries with 4 weeks of administration of the investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Nottingham, 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

  • Andrew Sparrow, BSc, BMedSci, BM,BS

    AstraZeneca Clinical Pharmacology Unit, Queens Medical Centre, Nottingham NG7 2UH

    PRINCIPAL INVESTIGATOR

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

August 5, 2009

First Posted

August 6, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 25, 2015

Record last verified: 2015-06

Locations

GB(1)