What side effects are associated with this type of intervention?

Common side effects observed in studies involving healthy subjects include nausea, headache, dizziness, and fatigue. For example, in the study of tribendimidine, the most common adverse events were vertigo, headache, and nausea. Similarly, in the study of varenicline for smoking cessation, the most frequently reported side effects were headache, dizziness, and nausea. These side effects are generally mild to moderate in intensity.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects often focus on understanding the pharmacokinetics, metabolism, and safety profiles of new drugs. These studies are crucial for determining how a drug is absorbed, distributed, metabolized, and excreted in the body. Similar to the study of Emraclidine, other drugs undergo rigorous testing in healthy volunteers to ensure their safety and efficacy before being approved for broader clinical use. This process helps in identifying the appropriate dosages and potential side effects, ensuring that the drugs are safe for subsequent trials in patients with specific conditions.

What other types of research exist?

Promising novel alternatives to Emraclidine for healthy subjects include: 1) Aclidinium bromide, which has shown significant improvements in lung function in COPD patients with a safety profile comparable to placebo. 2) Evacetrapib, which demonstrated a bioavailability of 44.8% and was well tolerated in healthy subjects. 3) Pretomanid, which was well tolerated across a range of doses in healthy Chinese adults, with a consistent pharmacokinetic profile. These alternatives have shown favorable pharmacokinetics and safety profiles in clinical studies.

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A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants

Phase 1

Waitlist Available

Research Sponsored by Cerevel Therapeutics, LLC

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 up to day 15

Awards & highlights

No Placebo-Only Group

Summary

This trial involves giving healthy adult men a single dose of a drug called emraclidine. The goal is to see how the drug moves through and is processed by their bodies.

Who is the study for?

This trial is for healthy adult men who can participate in a study to understand how the body processes and eliminates a drug called Emraclidine after taking it once. Specific eligibility details are not provided, but typically participants must meet certain health standards.

What is being tested?

The study is testing how Emraclidine, when taken orally by healthy men, moves through the body and is broken down or excreted. It involves measuring the drug's presence in blood and other bodily outputs to understand its behavior.

What are the potential side effects?

Since this trial involves healthy subjects and focuses on pharmacokinetics rather than treatment effects, side effects are not detailed here. However, as with any clinical trial, there may be risks which will be monitored throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 15 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Emraclidine 30 mgExperimental Treatment1 Intervention

Participants will receive a single oral dose of 30 milligrams (mg) (approximately 75 microcurie \[μCi\]) \[14C\]-emraclidine on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Emraclidine

2024

Completed Phase 1

~110

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 mechanisms of action for common treatments in healthy subjects, such as Emraclidine, involve understanding the pharmacokinetics and metabolism of the drug. This includes how the drug is absorbed, distributed, metabolized, and excreted. For Emraclidine, tracking the distribution and elimination using [14C]-emraclidine helps ensure the drug's safety and efficacy by determining optimal dosing and preventing toxic accumulation. This is particularly important for healthy subjects to ensure that the drug is effectively cleared from the body without adverse effects.

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