E1018 for Healthy Adults

Overseen By Eisai Medical Information

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eisai Inc.

Disqualifiers: Pregnancy, Childbearing potential, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy adults, it's likely that participants should not be on any medications that could affect the study results. Please consult with the study team for specific guidance.

What safety data exists for E1018 in humans?

There is no specific safety data available for E1018 in the provided research articles. ^{1 2 3 4 5}

What is the purpose of this trial?

The primary purpose of the study is to evaluate the safety and tolerability of single ascending oral doses of E1018 in healthy adult participants and to evaluate the pharmacokinetics (PK) of E1018 in plasma and urine after single oral dose administration.

Eligibility Criteria

This trial is for healthy adults who can safely receive oral medication. The study aims to include people who are likely able to handle a new drug without serious health risks, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

2. Body Mass Index (BMI) \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at Screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive single ascending oral doses of E1018 or placebo to assess safety, tolerability, and pharmacokinetics

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics after treatment

2-4 weeks

Treatment Details

Interventions

• E1018

Trial Overview The trial is testing the safety and how the body processes E1018, a potential malaria treatment. Participants will take single doses of E1018 or a placebo, with their blood and urine checked to see how the drug behaves.

Participant Groups

Group I: Cohort 6: E1018 or Placebo Experimental Treatment 2 Interventions

Group II: Cohort 5: E1018 or Placebo Experimental Treatment 2 Interventions

Group III: Cohort 4: E1018 or Placebo Experimental Treatment 2 Interventions

Group IV: Cohort 3: E1018 or Placebo Experimental Treatment 2 Interventions

Group V: Cohort 2: E1018 or Placebo Experimental Treatment 2 Interventions

Group VI: Cohort 1: E1018 or Placebo Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Eisai Inc.

Lead Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Findings from Research

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

An international study found that 70% of adverse drug events in humans were predicted by animal studies, indicating a good correlation between animal and human toxicity assessments.

While animal studies effectively identified many toxic effects, certain severe adverse events, like immuno-allergies, were not detected, highlighting the need for improved predictive tools in drug safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Are non-clinical studies predictive of adverse events in humans?]. Claude, N.[2019]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

A comprehensive analysis of 3,290 approved drugs and over 1.6 million reported adverse events revealed that animal studies can effectively predict human safety outcomes, particularly for conditions like QT prolongation and arrhythmias observed in dogs.

Despite the overall predictivity of animal safety data for humans, the study highlighted challenges in data curation and changes in methodologies over time that can affect the reliability of these analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans. Clark, M., Steger-Hartmann, T.[2018]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

References

1. United States pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]

2. France pubmed.ncbi.nlm.nih.gov

[Are non-clinical studies predictive of adverse events in humans?]. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A big data approach to the concordance of the toxicity of pharmaceuticals in animals and humans. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]