VA106483 and Alpha Blocker Interaction Study in Elderly Males

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The main purpose of this study is to investigate whether the hypotensive effects of an alpha-blocker are increased when VA106483 is given at the same time.

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

Details

• Lead Sponsor: Vantia Ltd
• Treatments: Adrenergic alpha-Antagonists

Criteria

Inclusion Criteria:

• Male aged 65 years of age and above

• No clinically important abnormal physical, laboratory or vital sign findings in the opinion of the Investigator

• Provision of written informed consent to participate

• No recent alpha-blocker therapy

• Not taking any concomitant medication known to be a cytochrome 3A4 inhibitor

• Not taking any prescribed or over the counter medications unless agreed with the Investigator and Sponsor

• No evidence of serious pathology or disease including poorly controlled endocrine disorders; active liver or biliary disease or severe kidney problems; syndrome of inappropriate antidiuretic hormone secretion

• No history of orthostatic hypotension or syncope.

• No known hypersensitivity to the IMP or alpha blocker, including severe lactose intolerance.

• No history of drug or alcohol abuse

• Negative for HIV, hepatitis B or C