CompletedPhase 1ACTRN12608000335392

A Phase I, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EMA401 Following Single Ascending Oral Dosing of EMA401.Na in Healthy Volunteers Administered Orally in the Fasted and Fed State.

Sponsor

Spinifex Pharmaceuticals Pty Ltd.

Enrollment

36 participants

Start Date

Jul 15, 2008

Study Type

Interventional

Conditions

Postherpetic Neuralgia

Summary

This study is to evaluate the pharmacokinetics (the way the body absorbs the drug) and to determine what the safest that can be used.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

This is a Phase I safety study testing increasing doses of a new pain medication called EMA401 in healthy volunteers. It is for healthy men aged 18 to 55 with normal blood pressure and heart function. Participants take single doses of the study drug or placebo and are monitored for 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.

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Interventions

EMA401 powder hand-filled into hard gelatin capsules. 4 out of 6 subjects in each cohort will take a single oral dose of the EMA401 following an overnight fast. There are 6 cohorts with dose levels

EMA401 powder hand-filled into hard gelatin capsules. 4 out of 6 subjects in each cohort will take a single oral dose of the EMA401 following an overnight fast. There are 6 cohorts with dose levels of 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. One dose level (cohort) will be asked to return to repeat the study with the drug being taken following a standard meal. There will be 6 subjects per cohort, 2 receiving placebo and 4 receiving the active drug.