Phase 1, single dose open label ADME study of [TFM-14C]BAY71-9678

• Research type

  Research Study

• Full title

  Single-center, open-label, non-randomised, non-placebo-controlled study to investigate the absorption, distribution, metabolism, excretion, mass balance, safety, tolerability, and pharmacokinetics after administration of a single oral solution dose of 100 mg BAY 71-9678 spiked with [TFM-14C] BAY 71-9678 in healthy, male subjects.

• IRAS ID

  25115

• Eudract number

  2009-011961-97

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The drug under investigation is BAY 71-9678. This drug is expected to be used as a treatment for pulmonary hypertension associated to chronic obstructive pulmonary disorder (COPD). COPD is a progressive disease that makes it hard to breathe, pulmonary hypertension is an even more severe status of the lung.The purpose of this study is to define the excretion of radiolabelled BAY 71-9678 and its breakdown products by measuring the concentration in blood, urine, faeces and hair over an 8-9 day period. "Radiolabelled" means that the test drug has a radioactive component [14C] to help track the course of the drug through the body.4 healthy male volunteers (maximum 6) between 30 and 65 years of age who meet the inclusion criteria will be enrolled in the study, in order to have 4 evaluable subjects for analysis.The study consists of a screening visit and a dosing/in-patient observation period. Participation in this study from admission to discharge is approximately 9 days. During the in-patient observation period subjects are required to stay in the clinic. This study will be conducted at one centre in Edinburgh.Healthy volunteers will be recruited by advertising in papers, radio websites and via a volunteer database.

• REC name

  Scotland A REC

• REC reference

  09/IEC02/11

• Date of REC Opinion

  2 Jul 2009

• REC opinion

  Favourable Opinion