What side effects are associated with this type of intervention?

Common treatments in pharmacokinetic and pharmacodynamic studies often report side effects such as nausea, vomiting, dizziness, headache, and gastrointestinal issues like constipation and dyspepsia. For example, in the study of MG1102, frequent adverse events included nausea (30.8%), abdominal pain (23.1%), constipation (23.1%), and dyspepsia (23.1%). Similarly, other treatments like CS-706 and topiramate also reported nausea, dizziness, and paresthesia as common side effects. These side effects are generally manageable and are typical in studies evaluating the safety and tolerability of new treatments.

What prior FDA approvals exist?

The FDA has approved various drugs and treatments that have undergone pharmacokinetics (PK) and pharmacodynamics (PD) studies in healthy subjects to ensure their safety, tolerability, and efficacy. These studies are crucial for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body, as well as its biological effects. Examples of such drugs include those used in clinical trials for conditions like hypertension, diabetes, and cancer, where initial PK and PD studies in healthy subjects help establish dosing regimens and safety profiles before proceeding to patient populations.

What other types of research exist?

Promising novel alternatives to ID119031166M for healthy subjects considering treatment in 2024 include selective RET inhibitors like Selpercatinib and Pralsetinib, which have shown strong clinical activity and favorable PK/PD profiles in recent studies. Additionally, Pembrolizumab and Atezolizumab, which are immune checkpoint inhibitors, have demonstrated efficacy and safety in various cancers and could be considered for further exploration in healthy subjects.

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ID119031166M Safety and Tolerability for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by IlDong Pharmaceutical Co Ltd

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening (day -28 to -3) until termination (approximately day 8 for sad and day 22 for mad)

Awards & highlights

Summary

This trial is testing a new drug called ID119031166M in healthy participants to see how safe it is and how the body processes it. Researchers want to understand how the drug is absorbed, distributed, metabolized, and excreted, as well as its effects on the body.

Who is the study for?

This trial is for healthy adults with a BMI of 18.5 to 30, normal kidney function, and no chronic diseases. It's open to both men and women who are not pregnant or breastfeeding and agree to use contraception. Up to half the participants may be of Japanese origin; the rest must be Caucasian.

What is being tested?

The study is testing ID119031166M, a new drug, against a placebo (a substance with no active drug). It aims to understand how safe it is, how well tolerated it is by the body, and how the body processes it while also looking at its effects on various bodily functions.

What are the potential side effects?

Since this trial involves healthy volunteers testing a new medication (ID119031166M), potential side effects are being investigated as part of the study objectives but are not specifically listed in provided information.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening (day -28 to -3) until termination (approximately day 8 for sad and day 22 for mad)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening (day -28 to -3) until termination (approximately day 8 for sad and day 22 for mad)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -28 to -3) until termination (approximately day 8 for sad and day 22 for mad) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)

Secondary study objectives

Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)

Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)

Dose-normalized AUC0-last

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: SAD: ID119031166MExperimental Treatment1 Intervention

Group II: MAD: ID119031166MExperimental Treatment1 Intervention

Group III: SAD: PlaceboPlacebo Group1 Intervention

Group IV: MAD: PlaceboPlacebo Group1 Intervention

Do I qualify?Apply below to find out

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

The most common treatments in healthy subjects often involve evaluating the pharmacokinetics (PK) and pharmacodynamics (PD) of new drugs. PK studies focus on how the drug is absorbed, distributed, metabolized, and excreted in the body, while PD studies assess the drug's biological effects and mechanisms of action. This information is essential for determining the safety, efficacy, and optimal dosing of new treatments, ensuring that they can be safely administered to patients with specific conditions. Understanding these mechanisms helps in predicting potential side effects and interactions with other medications, ultimately guiding the development of effective and safe therapeutic interventions.

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