Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

Phase 1

Completed

Brief Summary: The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.

Recruitment & Eligibility

Inclusion Criteria

Body Mass index (BMI) 18-30 kg/m2, inclusive.
Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology & urinalysis, as judged by the investigator

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 over the last 5 years or a cumulative total of >1 mSv per year of life
Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)

Arm && Interventions

Group	Intervention	Description
1	AZD5672	-

Primary Outcome Measures

Name	Time	Method
total radioactivity in plasma, whole blood, faeces and urine.	Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h
Additional metabolite identification	0.5h, 3h, 6h, 12h, 24h

Secondary Outcome Measures

Name	Time	Method
general safety assessments: AE reporting, physical examination, ECG, safety haematology and clinical chemistry assessment, vital signs	Screening, pre-dose, Visit 2 (residential period) and visit 3 follow up

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