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

NCT01284595 | Completed Phase 1

• 1 other identifier: D0102C00007
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Radioactive carbon; Absorption; Distribution; Metabolism; Excretion; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• To investigate the absorption, distribution, metabolism and excretion of AZD931 in human subjects

  Multiple blood , urine and faecal samples from pre-dose until 240 hours post last dose

• To investigate the pharmacokinetic variable of AZD8931 in plasma

  Multiple PK blood samples from pre-dose until 240 hours post last dose

Secondary Outcomes (2)

• To investigate the safety and tolerability of AZD8931 given orally

  Frequent safety measurements during the study from screening period to follow-up

• To investigate the AZD8931 metabolites variables in plasma

  Multiple PK blood samples from pre-dose until 240 hours post last dose

Study Arms (1)

AZD8931

EXPERIMENTAL

\[14C\] AZD8931

Drug: [14C] AZD8931

Interventions

[14C] AZD8931 DRUG

Single 160 mg oral dose administered on Day 1

AZD8931

Eligibility Criteria

• Age: 50 Years - 65 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 ≥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

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 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25007130 DERIVED

Related Links

• Clinical\_Study\_Protocol\_redacted

MeSH Terms

Interventions

AZD 8931

Study Officials

• Darren Wilbraham, MBBS, DCPSA

  Quintiles Drug Research Unit at Guy's Hospital

  PRINCIPAL INVESTIGATOR

• Mary Stuart

  AstraZeneca

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

GB (1)