What is the mechanism of action of this treatment?

Breast Cancer Resistance Protein (BCRP) inhibitors work by blocking the BCRP transporter, which is responsible for drug efflux out of cells. This inhibition can increase the intracellular concentration of drugs like Adagrasib, potentially enhancing their therapeutic effects. For healthy adults in clinical trials, understanding the impact of BCRP inhibition is essential to ensure accurate dosing, minimize adverse effects, and maximize the efficacy of the treatment being studied. This knowledge helps in tailoring personalized treatment plans and improving overall drug development processes.

What side effects are associated with this type of intervention?

Common treatments involving the inhibition of Breast Cancer Resistance Protein (BCRP) often include the use of specific inhibitors to study their effects on other drugs, such as Adagrasib. Known side effects of BCRP inhibitors can include gastrointestinal disturbances (nausea, vomiting, diarrhea), fatigue, and potential drug-drug interactions that may alter the pharmacokinetics of co-administered medications. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate any adverse effects effectively.

What prior FDA approvals exist?

FDA approvals for treatments in healthy adults often involve pharmacokinetic studies to understand drug interactions. While specific approvals for BCRP inhibitors in healthy adults are not detailed, similar studies have been conducted for various inhibitors to assess their impact on drug metabolism and efficacy. For instance, PCSK9 inhibitors like evolocumab and inclisiran have been approved for managing cholesterol levels, and their pharmacokinetics have been extensively studied. These studies help in understanding how inhibitors can affect the pharmacokinetics of other drugs, similar to the ongoing research on BCRP inhibitors and Adagrasib.

What other types of research exist?

Promising novel alternatives to BCRP inhibitors for healthy adults considering treatment in 2024 include the combination of fulvestrant plus everolimus, which has shown safety and efficacy in hormone-receptor positive, HER2-negative metastatic breast cancer. Additionally, the pan-PI3K inhibitor buparlisib in combination with fulvestrant has demonstrated activity and could be considered as an alternative treatment option.

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Adagrasib + Eltrombopag Drug Interaction in Healthy Adults

Phase 1

Waitlist Available

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1 and 8

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how a drug that blocks a breast cancer-related protein affects another drug called Adagrasib in healthy adults. By blocking this protein, researchers want to see if Adagrasib stays in the body longer or works better.

Who is the study for?

Healthy adults aged 18-60 with a BMI of 18.0 to 32.0 kg/m2 can join this trial. They must be in good health without significant medical issues, not pregnant or breastfeeding, and willing to use contraception. People with gastrointestinal conditions, drug allergies, serious diseases, recent drug abuse history or those using certain medications are excluded.

What is being tested?

The study is testing how an inhibitor of the Breast Cancer Resistance Protein (BCRP) affects the body's handling of Adagrasib when taken together in healthy subjects. It's a Phase 1 trial where participants first take Adagrasib alone and then combined with Eltrombopag.

What are the potential side effects?

As it's a Phase 1 trial primarily assessing safety and dosage levels, specific side effects aren't listed but may include reactions at the site of administration, general discomforts like headaches or nausea, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1 and 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1 and 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 and 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pharmacokinetics - AUC (adagrasib)

Pharmacokinetics - CL/F (adagrasib)

Pharmacokinetics - Cmax (adagrasib)

+3 more

Secondary study objectives

Adverse Events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Treatment AActive Control1 Intervention

Treatment A: A single oral dose of adagrasib 400 mg (2 × 200-mg tablets) on Day 1;

Group II: Treatment BActive Control1 Intervention

Treatment B: A single oral dose of eltrombopag 75 mg (1 × 75-mg tablet) plus adagrasib 400 mg (2 × 200-mg tablets) on Day 8.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast Cancer Resistance Protein (BCRP) inhibitors work by blocking the BCRP transporter, which is responsible for drug efflux out of cells. This inhibition can increase the intracellular concentration of drugs like Adagrasib, potentially enhancing their therapeutic effects. For healthy adults in clinical trials, understanding the impact of BCRP inhibition is essential to ensure accurate dosing, minimize adverse effects, and maximize the efficacy of the treatment being studied. This knowledge helps in tailoring personalized treatment plans and improving overall drug development processes.

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