Healthy Volunteers, Absorption, Distribution, Metabolism and Excretion (ADME) Study With Single Oral Administration of [14C] AZD8931

NCT ID: NCT01284595

Last Updated: 2014-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-05-31

Brief Summary

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Study to Assess the Absorption, Metabolism and Excretion of \[14C\]AZD8931 after a Single-Dose Oral Administration

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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AZD8931

\[14C\] AZD8931

Group Type EXPERIMENTAL

[14C] AZD8931

Intervention Type DRUG

Single 160 mg oral dose administered on Day 1

Interventions

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[14C] AZD8931

Single 160 mg oral dose administered on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a body mass index (BMI) of ≥19 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-smokers or ex-smokers who have stopped smoking for \>3 months before Visit 1 and have not used nicotine products for \>3 months
* Healthy Male volunteers aged 50 to 65 years, inclusive

Exclusion Criteria

* 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 12 months of the screening visit (Visit 1).
* History of alcohol abuse or excessive intake of alcohol defined as regular weekly intake of 28 units of alcohol or more (1 unit=25 mL spirits, 125 mL wine, 250 mL beer or lager)
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darren Wilbraham, MBBS, DCPSA

Role: PRINCIPAL_INVESTIGATOR

Quintiles Drug Research Unit at Guy's Hospital

Mary Stuart

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Ballard P, Swaisland HC, Malone MD, Sarda S, Ghiorghiu S, Wilbraham D. Metabolic disposition of AZD8931, an oral equipotent inhibitor of EGFR, HER2 and HER3 signalling, in rat, dog and man. Xenobiotica. 2014 Dec;44(12):1083-98. doi: 10.3109/00498254.2014.938257. Epub 2014 Jul 9.

Reference Type DERIVED
PMID: 25007130 (View on PubMed)

Related Links

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Other Identifiers

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D0102C00007

Identifier Type: -

Identifier Source: org_study_id

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