Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients [clinicaltrials:NCT02099591]

Bio2RDF identifier

NCT02099591

http://www.w3.org/2001/XMLSchema#string

Bio2RDF namespace

clinicaltrials

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Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT02099591

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identifiers.org URI

NCT02099591

acronym [clinicaltrials_vocabulary:acronym]

KODIAK16

http://www.w3.org/2001/XMLSchema#string

anticipated enrollment [clinicaltrials_vocabulary:anticipated-enrollment]

48

http://www.w3.org/2001/XMLSchema#integer

arm group [clinicaltrials_vocabulary:arm-group]

NCT02099591 arm group 570f70c31250fb3595382cd05cc0650f [clinicaltrials_resource:NCT02099591/arm-group/570f70c31250fb3595382cd05cc0650f]

NCT02099591 arm group 94ed3340890a107f07b87c95ba1714a1 [clinicaltrials_resource:NCT02099591/arm-group/94ed3340890a107f07b87c95ba1714a1]

NCT02099591 arm group 9b9cc26167488bbe1fec1bbe0d1ab34a [clinicaltrials_resource:NCT02099591/arm-group/9b9cc26167488bbe1fec1bbe0d1ab34a]

NCT02099591 arm group a94ba4790ecefa97dbf90bfeb0604507 [clinicaltrials_resource:NCT02099591/arm-group/a94ba4790ecefa97dbf90bfeb0604507]

NCT02099591 arm group c74ebf2763db16d713858c9c3db9a1b5 [clinicaltrials_resource:NCT02099591/arm-group/c74ebf2763db16d713858c9c3db9a1b5]

NCT02099591 arm group d31f4478364981ba5e071a8bea107c3c [clinicaltrials_resource:NCT02099591/arm-group/d31f4478364981ba5e071a8bea107c3c]

authority [clinicaltrials_vocabulary:authority]

clinicaltrials_resource:3b210bdeb29f01e0e61395f51dfc3e60

brief summary [clinicaltrials_vocabulary:brief-summary]

To characterize the pha ...... d induced constipation (OIC).

http://www.w3.org/2001/XMLSchema#string

brief title [clinicaltrials_vocabulary:brief-title]

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

http://www.w3.org/2001/XMLSchema#string

clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:0093ca59a731370fa92553ce34e7c16b]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:216cc196f73d88c007a056c749908d3d]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:45060a6a458d16130da46d39ba3438ac]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:4818bf11682b00bb94b5b63a8f7ff41e]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:6927b66aa737f68fb4f4afe37459e233]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:7d19f35e8efbe6775ac9c65bfbefd156]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:8017f3907beb31ed4125486575e89276]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:9fcc0cfa1567c21aff0337dffa288ef8]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:f188d17c482947f2d4f6152e32f09f44]

clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:19bc739afee13e9c578e37dff276e7c8]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:33d34c1230c1af900ac094b014e05352]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:39346608f07f68ed6d2160f30c75506a]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:649f9d7d746a2563f564bd62243e5e59]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:c3075570449afb5581b57168feb8c400]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:cbe3ea7a9a222547cc0115e0c9ac85a0]

Pharmacokinetics after single oral dose of Naloxegol by assessment of area under the plasma concentration-time curve from zero extrapolated to infinity (AUC) Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours [clinicaltrials_resource:e5391e64f510388cc897ad83a3a60523]

completion date [clinicaltrials_vocabulary:completion-date]

2017-01-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

download date [clinicaltrials_vocabulary:download-date]

ClinicalTrials.gov processed this data on August 10, 2015

http://www.w3.org/2001/XMLSchema#string

eligibility [clinicaltrials_vocabulary:eligibility]

eligibility for clinicaltrials:NCT02099591 [clinicaltrials_resource:e772ce0d707ee297db985e172ba380b3]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2014-02-13T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

has expanded access [clinicaltrials_vocabulary:has-expanded-access]

No

http://www.w3.org/2001/XMLSchema#string

intervention [clinicaltrials_vocabulary:intervention]

Naloxegol [clinicaltrials_resource:57db982cac93ba9ce938a08d1191a6e7]

Naloxegol [clinicaltrials_resource:acc455e353006240e28a6ebc7d3bb65f]

is fda regulated [clinicaltrials_vocabulary:is-fda-regulated]

No

http://www.w3.org/2001/XMLSchema#string

keyword [clinicaltrials_vocabulary:keyword]

Colonic Inertia

http://www.w3.org/2001/XMLSchema#string

Constipation

http://www.w3.org/2001/XMLSchema#string

Dyschezia

http://www.w3.org/2001/XMLSchema#string

Naloxegol

http://www.w3.org/2001/XMLSchema#string

OIC

http://www.w3.org/2001/XMLSchema#string

Opioid induced constipation

http://www.w3.org/2001/XMLSchema#string

Opioids

http://www.w3.org/2001/XMLSchema#string

Paediatric

http://www.w3.org/2001/XMLSchema#string

Pharmacokinetics

http://www.w3.org/2001/XMLSchema#string

Phase 1

http://www.w3.org/2001/XMLSchema#string

lastchanged date [clinicaltrials_vocabulary:lastchanged-date]

2015-07-21T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

AstraZeneca [clinicaltrials_resource:a083735aebc9a325683091959d090667]

location [clinicaltrials_vocabulary:location]

Research Site [clinicaltrials_resource:b03e51f83656a48fca78ef09bce97b2e]

nct id [clinicaltrials_vocabulary:nct-id]

NCT02099591

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number of arms [clinicaltrials_vocabulary:number-of-arms]

6

http://www.w3.org/2001/XMLSchema#integer

official title [clinicaltrials_vocabulary:official-title]

A Phase I Open-Label Multicent ...... ceiving Treatment With Opioids

http://www.w3.org/2001/XMLSchema#string

org study id [clinicaltrials_vocabulary:org-study-id]

D3820C00016

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overall contact [clinicaltrials_vocabulary:overall-contact]

AstraZeneca Clinical Study Information Center [clinicaltrials_resource:10543ee2afbb5dda4b9fa1c83633e27e]

overall contact backup [clinicaltrials_vocabulary:overall-contact-backup]

AstraZeneca Clinical Study Information Center [clinicaltrials_resource:a8cee37e19e41324adcccfc80f550060]

overall status [clinicaltrials_vocabulary:overall-status]

Recruiting [clinicaltrials_resource:5231dee7156b84b0d1854de1a18dd169]

oversight [clinicaltrials_vocabulary:oversight]

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) [clinicaltrials_resource:c75e4b8f5e8d452c8f359ec8c4814a7d]

phase [clinicaltrials_vocabulary:phase]

Phase 1 [clinicaltrials_resource:ee4650e51426c7487977eeea8e7e6850]

primary completion date [clinicaltrials_vocabulary:primary-completion-date]

2017-01-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

secondary id [clinicaltrials_vocabulary:secondary-id]

UTN: U1111-1154-5575

http://www.w3.org/2001/XMLSchema#string

source [clinicaltrials_vocabulary:source]

AstraZeneca [clinicaltrials_resource:a083735aebc9a325683091959d090667]

start date [clinicaltrials_vocabulary:start-date]

2014-11-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT02099591 study design [clinicaltrials_resource:5d08eb59b44835ab64e157d45205b80e]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT02099591

verification date [clinicaltrials_vocabulary:verification-date]

2015-07-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

identifier

clinicaltrials:NCT02099591

http://www.w3.org/2001/XMLSchema#string

title

Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients

@en

inDataset

clinicaltrials_resource:bio2rdf.dataset.clinicaltrials.R3

type

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]

label

Phase I Pharmacokinetics and S ...... s [clinicaltrials:NCT02099591]

@en