CompletedPhase 1ACTRN12609000489291

A phase I, randomised, double-blind, placebo controlled, dose ranging study to evaluate the safety, tolerability and pharmacokinetics of EMA401 following multiple oral dosing in healthy male subjects.

Sponsor

Spinifex Pharmaceuticals Pty Ltd

Enrollment

36 participants

Start Date

Apr 6, 2009

Study Type

Interventional

Conditions

Postherpetic Neuralgia

Summary

A multiple ascending dose study to determine the safety, tolerability and pharmacokinetics of EMA401 in healthy male volunteers aged 18-55

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This is an early-stage safety study of an experimental pain medication called EMA401 in healthy male volunteers. Participants receive multiple doses of the drug or a placebo to assess how the body handles the medication and whether it causes any side effects.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

EMA401 powder hand-filled into hard VCaps Plus (Registered Trademark) capsules. 8 subjects in each cohort group will take a single oral dose of the EMA401 for seven consecutive days. There are 3 cohort groups with dose levels of 10 mg (Group 1), 25 mg (Group 2) and 50 mg (Group 3). There will be 12 subjects per cohort group, 4 receiving placebo and 8 receiving the active drug.