A Study to Assess the Systemic Pharmacokinetics, Metabolism and Excretion Routes of YM178 in Man, After Administration of Radio-labeled YM178

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study aims to assess the routes and the extent of metabolism and excretion of YM178 after a single dose of 14C-radiolabeled YM178 administered as a drinking solution in healthy male volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Treatments: Mirabegron

Criteria

Inclusion Criteria:

• Body weight between 60 and 100 kg, and BMI ≤30 kg/m2

Exclusion Criteria:

• Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used

• Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug

• Any clinically significant history of upper gastrointestinal symptoms (such as nausea, vomiting, abdominal discomfort or upset, or heartburn) in the 4 weeks prior to admission to the Research Unit

• Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic

• Abnormal pulse rate measurement (<40 or >90 bpm) taken by manual counting at the pre-study visit after subject has been resting in supine position for 5 min

• Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 min as follows:

• Systolic blood pressure <95 or >160 mmHg;

• Diastolic blood pressure <40 or >95 mmHg.

• Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and/or a fall of ≥ 20 mmHg in systolic blood pressure after 2 min standing (preceded by 5 min. supine rest) and/or an increase in pulse rate of ≥ 20 bpm

• Regular use of any prescribed or OTC (over the counter) drugs except paracetamol up to 3 g/day, in the 4 weeks prior to admission to the Research Unit OR any use of such drugs in the 2 weeks prior to admission to the Research Unit

• History of drug abuse at any time, OR any use of drugs of abuse within 3 months prior to admission to the Research Unit

• History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Research Unit

• History of drinking more than 21 units of alcohol per week (1 unit = 270 cc of beer or 40 cc of spirits or 1 glass of wine) within 3 months prior to admission to the Research Unit

• Donation of blood or blood products within 3 months prior to admission to the Research Unit

• Positive serology test for HBsAg, HAV IgM, anti-HCV or anti-HIV 1+2.

• Participation in any clinical study within 3 months, or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study

• Subjects having received YM178 previously

• Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical trial in the previous year