CompletedPhase 1ACTRN12610000620022

A Phase I Multiple Ascending Dose Study of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects

A Phase I Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EMA401 Sodium Salt Administered Orally in Healthy Elderly Subjects

Sponsor

Spinifex Pharmaceuticals Pty Ltd

Enrollment

32 participants

Start Date

Jul 14, 2010

Study Type

Interventional

Conditions

Postherpetic Neuralgia

Summary

This study is designed to assess the safety, tolerability and pharmacokinetic profile of seven (7) consecutive daily doses of EMA401 Sodium Salt in an elderly population (aged 56 years and over) at dose levels of 50 and 100 mg.

Eligibility

Sex: Both males and femalesMin Age: 56 Yearss

Plain Language Summary

Simplified for easier understanding

This is an early-phase safety study testing increasing doses of a new pain medication called EMA401 in healthy older adults aged 56 and above. Participants must be healthy, have normal blood pressure and heart function, and not be taking significant medications.

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 Sodium Salt administered orally once daily for 7 days. The starting dose level is 50 mg for 7 days (Cohort 1) with provision to escalate to 100 mg for 7 days (Cohort 2) subject to Data Safety

EMA401 Sodium Salt administered orally once daily for 7 days. The starting dose level is 50 mg for 7 days (Cohort 1) with provision to escalate to 100 mg for 7 days (Cohort 2) subject to Data Safety Monitoring Committee (DSMC) review.