RecruitingACTRN12614000451606

An evaluation of the drug interaction potential of modafinil in healthy volunteers, using a cocktail approach

An investigation of the proportional change in area under the concentration-time curves for five orally administered CYP P450 probes (caffeine, losartan, omeprazole, dextromethorphan, midazolam) when administered with and without single-dose and steady-state oral modafinil, in twelve healthy adult volunteers.

Sponsor

Flinders University

Enrollment

12 participants

Start Date

Nov 28, 2014

Study Type

Interventional

Conditions

Drug-drug interactions

Summary

To assess the capacity of a vigilance promoting agent (modafinil) to ‘perpetrate’ metabolic drug interactions that may lead to adverse effects.

Eligibility

Sex: MalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a wakefulness-promoting drug called modafinil (sometimes used for shift work or narcolepsy) interacts with other medications by affecting how the body processes them in the liver. Healthy male volunteers will take a combination of probe drugs alongside modafinil, and blood samples will be taken to measure how the drugs are metabolised. You may be eligible if: - You are a healthy male - You are between 18 and 40 years old You may NOT be eligible if: - You are female - You are currently taking any prescription medications - You have significant health conditions - You are unable to comply with the study requirements Talk to your doctor about whether this trial might be right for you.

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

Simultaenous administration of single doses of five drugs (caffeine 100mg, losartan 25mg, omperazole 20mg, dextromethorphan 30mg, midazolam 2mg) on three occasions on study days 0,1 and 7. These drugs will be administered orally (as tablets - caffeine, losartan, omeprazole; as solutions diluted in water - midazolam, dextromethorphan) with water. Administration of modafinil 200mg daily for seven days on study Days 1 to 7. The modafinil will be given as tablets with water. A single modafinil plasma concentration will be measured post-dose on Day 7 to monitor adherence and to ensure steady-state has been achieved.

Locations(1)

Flinders Medical Centre - Bedford Park

SA, Australia

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ACTRN12614000451606