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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000782639

Enrollment

Registered

2005-12-07

Start date

2006-01-10

Completion date

2006-02-22

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To determine how a new implant design of EPT1647 works in the body and to review any side effects that may occur.

Interventions

EPT1647 is a derivative of MSH which has been shown to increase eumelanin levels in humans. This study will evaluate the safety and pharmacokinetic profiles of a new formulation of EPT1647 over 30 days.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Educational / counselling / training

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 45 Years

Healthy volunteers

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

Outcome results