A phase I study to assess the pharmacokinetics of a single dose of a slow-release solid injection of EPT1647 in healthy male volunteers

Phase 1

Completed

• Conditions: /A; Healthy male volunteers; N/A; Other -

• Registration Number: ACTRN12605000782639
• Lead Sponsor: Epitan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-07
• Study Completion: 2006-07-27
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

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

Inclusion Criteria

* Healthy caucasian * No history of Melanoma includinjg in a first degree relative* No significant medical history or disorder* Take precautions to prevent pregnancy during and upto 3 months after study.* No history of drug or alcohol abuse.

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics of a new slow-release solid dose injectable form of EPT1647 administered subcutaneously to healthy men.[Measured prior to administration of EPT1647, 4, 8 and 12 hours after administration of EPT1647 on day 1, then at days 2, 3, 4, 5, 6, 8, 10, 12, 15 and 30.]

Secondary Outcome Measures

Name	Time	Method
To Determine the safety profile of a new slow relase solid dose injectable form of EPT1647 administered subcutaneously to healthy men.[]