Open Label, Healthy Volunteers, ADME Study With Single Oral Administration of [14C] AZD5069

NCT01332903 | Completed Phase 1

• 1 other identifier: D3550C00013
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\] AZD5069.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of [14C] radioactivity in plasma and whole blood

  To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring the amount of \[14C\] radioactivity in plasma and whole blood and the resulting area under the concentration-time curve from zero extrapolated to infinity (AUC), to the last measurable concentration (AUC(0 t)).

  From pre-dose until 168 hours post last dose

• To investigate the absorption, distribution, metabolism and excretion of AZD5069 in human subjects by measuring Plasma [14C] AZD5069:AZD5069 (cold) ratios for concentrations and selected pharmacokinetic parameters (AUCs and Cmax).

  From pre-dose until 168hours post last dose

• To investigate the excretion of AZD5069 in human subjects by measuring the amount and percentage of radioactive dose recovered in urine, faeces, and renal clearance.

  From pre-dose until 168hours post last dose

Secondary Outcomes (1)

• To investigate the safety and tolerability of AZD5069 given orally

  From screening visit, Day 12, up to follow up visit

Study Arms (1)

1

EXPERIMENTAL

\[14C\] AZD5069

Drug: [14C] AZD5069

Interventions

[14C] AZD5069 DRUG

Single 120 mg oral dose administered on Day 1

1

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a body mass index (BMI) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg.
• Regular daily bowel movements (ie, production of at least 1 stool per day).
• Non-smoker or ex-smoker who has not used tobacco or nicotine products for ≥6 months prior to Visit 1
• Healthy Male volunteers aged 50 and over

You may not qualify if:

• Healthy volunteers who have been exposed to radiation levels above background (eg, through X-ray examination) of \>5 mSv in the last year, \>10 mSv in the last 5 years, or a cumulative total of \>1 mSv per year of life
• Participation in any prior radiolabelled study within last 5 years
• History of alcohol abuse or excessive intake of alcohol as judged by the investigator.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, 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

• Prof. Tim Mant, FRCP, FFPM

  Quintiles Drug Research Unit at Guy's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: April 11, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

GB (1)