Evidence map›Paper›PMID 29856004›Full record

Trial reportDrugs in R&D2018

Pharmacokinetics of the Oral Selective CXCR2 Antagonist AZD5069: A Summary of Eight Phase I Studies in Healthy Volunteers.

Marie Cullberg, Cecilia Arfvidsson, Bengt Larsson, Anna Malmgren, Patrick Mitchell, Ulrika Wählby Hamrén, Heather Wray

8 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Drugs in R&D, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 8 registered trials, which are not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
0.7field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00953888 phase1completednot on this map

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 After Single Ascending Doses in Healthy Male and/or Female Subjects

TypeinterventionalSponsorAstraZenecaRan2009 to 2009Enrolled203ConditionsHealthyArmsAZD5069, Placebo
NCT01051505 phase1completednot on this map

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 After Administration of Multiple Ascending Doses for 8 Days in Healthy Male or Female Subjects

TypeinterventionalSponsorAstraZenecaRan2010 to 2010Enrolled8ConditionsHealthyArmsAZD5069, Placebo
NCT01083238 phase1completednot on this map

A Phase I, Two-part Study to Investigate the Effects of Food on the PK, Safety and Tolerability of a Single Oral Dose of AZD5069 (120 mg) in Healthy Adult Volunteers (Part A) and to Compare the PK of AZD5069 in Adult and Elderly Healthy Volunteers (Part B)

TypeinterventionalSponsorAstraZenecaRan2010 to 2010Enrolled24ConditionsChronic Obstructive Pulmonary DiseaseArmsAZD5069
NCT01100047 phase1completednot on this map

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses

TypeinterventionalSponsorAstraZenecaRan2010 to 2011Enrolled63ConditionsHealthyArmsAZD5069, Placebo
NCT01332903 phase1completednot on this map

A Phase I, Open-Label Study to Characterise the Absorption, Distribution, Metabolism and Excretion Following a Single Oral Dose of [14C]AZD5069 in Healthy Male Volunteers

TypeinterventionalSponsorAstraZenecaRan2011 to 2011Enrolled6ConditionsHealthyArms[14C] AZD5069
NCT01480739 phase1completednot on this map

A Randomised, Double-blind, Placebo-Controlled, Two-way Cross-over, Single Centre Study in Healthy Subjects to Assess the Effect of Oral Dosing of AZD5069 on Neutrophil Number and Function in Peripheral Blood and the Ability to Recruit Neutrophils Into the Circulation After Exercise and Subcutaneous

TypeinterventionalSponsorAstraZenecaRan2011 to 2012Enrolled30ConditionsChemokine Receptor 2 (CXCR2) AntagonistArms100 mg (50 mg x 2) AZD5069, 100 mg Placebo
NCT01735240 phase1completednot on this map

An Open-label, Fixed-sequence, Single-centre Phase I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of AZD5069 After Oral Administration of a Single Dose AZD5069 to Healthy Male Volunteers

TypeinterventionalSponsorAstraZenecaRan2012 to 2013Enrolled15ConditionsAsthma,, Pharmacokinetics,, Cmax,, Tmax,ArmsAZD5069, Ketoconazole
NCT01989520 phase1completednot on this map

An Open-label, Single Centre Relative Bioavailability Study With an Adaptive Design Comparing up to 5 Solid Oral AZD5069 Formulations After Single Dose Administration to Healthy Volunteers

TypeinterventionalSponsorAstraZenecaRan2014 to 2014Enrolled36ConditionsUncontrolled and Persistent AsthmaArmsPhase IIb formulation, Putative phase III formulation, Slow dissolution variant 1, Slow dissolution variant 2, Test treatment E
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. NET Gain for Sepsis Research: A New Approach to Assess Neutrophil Function in Patients.American journal of respiratory and critical care medicine · 2019
    Article
  14. Review
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Marie CullbergEarly Clinical Development, IMED Biotech Unit, AstraZeneca, Pepparedsleden 1, Mölndal, 431 83, Gothenburg, Sweden. marie.cullberg@astrazeneca.com.
Cecilia ArfvidssonEarly Clinical Development, IMED Biotech Unit, AstraZeneca, Pepparedsleden 1, Mölndal, 431 83, Gothenburg, Sweden.
Bengt LarssonEarly Clinical Development, IMED Biotech Unit, AstraZeneca, Pepparedsleden 1, Mölndal, 431 83, Gothenburg, Sweden.
Anna MalmgrenRespiratory, Inflammation and Autoimmunity, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.
Patrick MitchellEarly Clinical Development, IMED Biotech Unit, AstraZeneca, Boston, USA.
Ulrika Wählby HamrénEarly Clinical Development, IMED Biotech Unit, AstraZeneca, Pepparedsleden 1, Mölndal, 431 83, Gothenburg, Sweden.
Heather WrayEarly Clinical Development, IMED Biotech Unit, AstraZeneca, Pepparedsleden 1, Mölndal, 431 83, Gothenburg, Sweden.
AstraZeneca (Sweden) · SEAstraZeneca (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe aim of this study was to summarise the pharmacokinetic findings from eight phase I studies in healthy volunteers given oral AZD5069, a selective small-molecule CXCR2 antagonist.

methods240 healthy volunteers across eight phase I studies received single (0.1-200 mg) or multiple once- or twice-daily (10-120 mg) oral AZD5069 as solution, suspension, capsules or tablets. Pharmacokinetics were evaluated using non-compartmental analysis methods.

resultsAZD5069 was rapidly absorbed (time to maximum concentration ~ 2 h) under fasting conditions. A high-fat, high-calorie meal delayed and reduced the peak plasma AZD5069 concentration (C

conclusionsAZD5069 demonstrated predictive linear pharmacokinetics with low intra- and moderate inter-subject variability and no major influences from ethnicity, age, food or formulation. Half-life data indicated suitability for twice-daily dosing. CLINICALTRIALS. GOV IDENTIFIERS: NCT00953888, NCT01051505, NCT01083238, NCT01100047, NCT01332903, NCT01480739, NCT01735240, NCT01989520.

Indexed as

AdolescentAdultAgedAge FactorsBiological AvailabilityCapsulesClinical Trials, Phase I as TopicDose-Response Relationship, DrugDrug InteractionsFemaleFood-Drug InteractionsHealthy VolunteersHumansKetoconazoleMaleMiddle AgedCapsulesKetoconazoleN-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamidePyrimidinesSolutionsSulfonamidesSuspensionsTablets

Identifiers

PMID29856004
PMCPMC5995788
OpenAlexW2806100469

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 2 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.