16 Participants Needed

Combination Drugs for Drug Interactions

MP
DH
Overseen ByDeena Hadi, BS
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Washington State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of this study is to confirm the feasibility of using a panel of endogenous substrates/metabolites as a robust biomarker of OCTs and OATs by conducting a controlled, comprehensive clinical drug-drug interaction study in healthy adult volunteers. Metformin and furosemide will be used as probe drugs for OCTs and OATs, respectively; cimetidine and probenecid will be used as corresponding inhibitors. Results from this study will validate this novel approach, which will be extended to children by collaborators at Children's Mercy Hospital in Kansas City, MO.

Will I have to stop taking my current medications?

Yes, you must stop taking any medications or supplements that could interfere with the study drugs. The trial requires participants to be medication-free to ensure accurate results.

Is the combination of drugs including Cimetidine generally safe for humans?

Cimetidine has been widely used for years, but it can interact with many other drugs, potentially causing adverse effects. It's important to monitor for interactions, especially if taking multiple medications, as Cimetidine can affect how other drugs are absorbed and eliminated in the body.12345

What makes this drug combination unique for treating drug interactions?

This drug combination is unique because it includes cimetidine, which is known to interact with many drugs by inhibiting liver enzymes and affecting drug metabolism and excretion, potentially altering the effects of other drugs in the combination.25678

What data supports the effectiveness of the drug combination involving Cimetidine, Tagamet, Furosemide, Lasix, MetFORMIN, Glucophage, Glucophage XR, Fortamet, Glumetza, Riomet, Probenecid, Benemid, Probecid?

The research highlights that Cimetidine, a component of the drug combination, is known for its interactions with other drugs due to its effect on liver enzymes, which can alter the metabolism and excretion of various medications. This suggests that careful monitoring is needed when using Cimetidine in combination with other drugs to ensure effectiveness and safety.25689

Are You a Good Fit for This Trial?

Healthy adults aged 18-65 who don't consume caffeine or alcohol before and during the study, aren't on interfering meds or supplements, can commit time to participate, and use certain birth control methods. Excluded are those under 18 or over 65, tobacco/cannabis users, pregnant/nursing women, with chronic illnesses like kidney disease or diabetes.

Inclusion Criteria

Are willing to stop consuming caffeinated beverages or other caffeine-containing products the evening before and the morning of the first day of each study arm
Are willing to stop drinking alcoholic beverages for at least 1 day prior to any study day and during the study day
Are not taking any medications (prescription and non-prescription) or dietary/herbal supplements that can interfere with your ability to eliminate the study drugs from your body
See 3 more

Exclusion Criteria

Are taking medications or dietary/herbal supplements that can interfere with your ability to eliminate the study drugs from your body
You use tobacco products like cigarettes, e-cigarettes, or chewing tobacco.
You use cannabis products, such as marijuana or hemp, that contain substances like THC and CBD.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment - Arm 1A: Metformin Alone

Administration of a single dose of metformin (50 mg) by mouth. Plasma and urine collected from 0-24 hours.

1 day
1 visit (in-person)

Washout Period

A washout period of at least 7 days between treatment arms to prevent drug interaction effects.

7 days

Treatment - Arm 1B: Metformin + Cimetidine

Administration of cimetidine (400 mg) followed by metformin (50 mg). Plasma and urine collected from 0-24 hours.

1 day
1 visit (in-person)

Washout Period

A washout period of at least 7 days between treatment arms to prevent drug interaction effects.

7 days

Treatment - Arm 2A: Furosemide Alone

Administration of a single dose of furosemide (5 mg) by mouth. Plasma and urine collected from 0-24 hours.

1 day
1 visit (in-person)

Washout Period

A washout period of at least 7 days between treatment arms to prevent drug interaction effects.

7 days

Treatment - Arm 2B: Furosemide + Probenecid

Administration of probenecid (1,000 mg) followed by furosemide (5 mg). Plasma and urine collected from 0-24 hours.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cimetidine
  • Furosemide
  • MetFORMIN
  • Probenecid
Trial Overview The trial tests how well a biomarker panel can track kidney transporter activity using Metformin and Furosemide as probes for transporters OCTs/OATs. Cimetidine and Probenecid will be used to inhibit these transporters. The goal is to validate this method for future pediatric studies.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Arm 2B: furosemide + probenecidExperimental Treatment2 Interventions
Group II: Arm 2A: furosemide alone (baseline)Experimental Treatment1 Intervention
Group III: Arm 1B: metformin + cimetidineExperimental Treatment2 Interventions
Group IV: Arm 1A: metformin alone (baseline)Experimental Treatment1 Intervention

Cimetidine is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as Tagamet for:
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Approved in United States as Tagamet for:
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Approved in Canada as Tagamet for:
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Approved in Japan as Tagamet for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials
114
Recruited
58,800+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials
2,103
Recruited
2,760,000+

Published Research Related to This Trial

Antacids and adsorbents are generally considered safe and free from adverse effects, but they can interact with certain primary medications, potentially reducing their effectiveness.
The most significant interactions occur with drugs like ferrous sulfate, isoniazid, and tetracycline, which have strong evidence of clinical importance, while many reported interactions in the literature are overstated.
Drug-antacid interactions: assessment of clinical importance.D'Arcy, PF., McElnay, JC.[2019]
Patients with chronic disorders or those taking multiple medications are at a higher risk for drug interactions, which can lead to treatment failures and adverse reactions.
Drug interactions can occur through various mechanisms, including absorption issues, protein binding displacement, metabolism variability via the cytochrome P450 system, and renal excretion problems, highlighting the importance of monitoring drug levels, especially for medications with a narrow safety margin.
Drug interactions: keeping it straight.Anastasio, GD., Cornell, KO., Menscer, D.[2005]
Cimetidine, an antiulcer medication, significantly inhibits liver enzymes that can alter the metabolism of various drugs, including warfarin and theophylline, which may lead to clinically important drug interactions.
Cimetidine can also raise gastric pH and affect liver blood flow, potentially exacerbating the effects of other medications, such as increasing the myelosuppressive effects of nitrosoureas and altering the absorption of ketoconazole.
Cimetidine drug interactions.Greene, WL., Self, TH., Levinson, MJ.[2013]

Citations

Drug-antacid interactions: assessment of clinical importance. [2019]
Drug interactions: keeping it straight. [2005]
Cimetidine drug interactions. [2013]
Drug interactions involving cimetidine--mechanisms, documentation, implications. [2019]
Femoxetine and cimetidine: interaction in healthy volunteers. [2019]
Lack of inhibition of tolbutamide hydroxylation by cimetidine in man. [2019]
Interaction of cimetidine with other drugs. [2019]
8.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Cytochrome P450 3A4 Induction: Lumacaftor versus Ivacaftor Potentially Resulting in Significantly Reduced Plasma Concentration of Ivacaftor. [2020]
Effect of cimetidine on the pharmacokinetics of temafloxacin. [2018]
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