A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Ascending Doses of AZD5069 in Healthy Volunteers

NCT01051505 | Completed Phase 1

• 1 other identifier: D3550C00007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the safety and tolerability of AZD5069 at steady-state, following twice a day oral dosing in healthy subjects. AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy's Hospital, London. This is the second time that AZD5069 will be administered to humans in clinical trials. We are conducting this study to determine whether AZD5069 is safe and well tolerated by healthy males and females at different dose levels over an 8-day dosing period. We will also be studying how quickly AZD5069 is absorbed into and cleared by the body. It is planned that there will be up to 3 dose groups in the study and each group will consist of up to 12 volunteers, with 9 receiving the active drug and 3 receiving placebo. The study involves 3 visits over approximately 8 weeks, and will include 1 residential visit lasting 10 nights and a follow up.

Conditions

Healthy

Keywords

Phase I; multiple ascending dose; Safety; Tolerability; Healthy Volunteer

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

  Baselines assessments at Visit 1 (enrolment) or pre-dose on Day 1 with assessments during Visit 2 at protocol defined time-points post-dose until 96hr post final 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

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD5069

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD5069 DRUG

oral suspension dose of AZD5069. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7

1

Placebo DRUG

oral suspension dose of matched placebo. Multiple doses will be given once daily on day 1 and day 8 and twice daily on days 2 to 7

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated, written informed consent
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
• Healthy male or female (of non child bearing potential)volunteers with suitable veins for cannulation or repeated venepuncture

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
• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London Bridge, 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: 29856004 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Interventions

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

Study Officials

• Darren Wilbraham, MBBS, DCPSA

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 18, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

GB (1)