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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [14C] AZD8931

• Registration Number: NCT01284595
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2011-03
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD8931	[14C] AZD8931	\[14C\] AZD8931

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom