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Anti-tumor antibiotic

Part A: Open Label for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Shionogi

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 venous: days 1-5, 8-12, and 15-19 (predose, up to 96 hours post dose); capillary: days 1, 2, 8, and 9 (up to 24 hours post dose)

Awards & highlights

Study Summary

This trial aims to study different versions of a drug called S-337395.

Who is the study for?

This trial is for healthy adults with a BMI of 18.5 to 30 who agree to use contraception according to local guidelines. People can't join if they've had certain cancers in the past, are allergic to S-337395 or its components, have liver or gallbladder issues (except Gilbert's syndrome), or have major health problems that could affect the study.Check my eligibility

What is being tested?

The study is testing different ways of delivering a drug called S-337395 in healthy people. Some participants will get the actual drug and others will receive a placebo, which has no active ingredients. The goal is to see how well each formulation works and how it's processed by the body.See study design

What are the potential side effects?

Since this trial involves healthy volunteers and tests new formulations of S-337395, potential side effects aren't specified but may include reactions at the site of administration, general discomforts like headaches or nausea, and possibly allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ venous: days 1-5, 8-12, and 15-19 (predose, up to 96 hours post dose); capillary: days 1, 2, 8, and 9 (up to 24 hours post dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~venous: days 1-5, 8-12, and 15-19 (predose, up to 96 hours post dose); capillary: days 1, 2, 8, and 9 (up to 24 hours post dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and venous: days 1-5, 8-12, and 15-19 (predose, up to 96 hours post dose); capillary: days 1, 2, 8, and 9 (up to 24 hours post dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Plasma Concentration of S-337395

Part B: Number of Participants Experiencing Treatment-emergent Adverse Events

Secondary outcome measures

Part A: Number of Participants Experiencing Treatment-emergent Adverse Events

Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples)

Part B: Plasma Concentration of S-337395

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B: Double BlindExperimental Treatment2 Interventions

Participants will receive S-337395 or placebo.

Group II: Part A: Open LabelExperimental Treatment1 Intervention

Participants will receive different formulations of S-337395 without food and with food.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ShionogiLead Sponsor

116 Previous Clinical Trials

41,436 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are prospective participants currently able to enroll in this medical study?

"According to the information available on clinicaltrials.gov, recruitment for this specific trial is currently closed. Despite being posted initially on February 14th, 2024 and last updated on February 13th, 2024, it is no longer accepting new candidates. However, there are a substantial number of other trials actively seeking participants - precisely 809 at present."

Answered by AI

Does this study include individuals who are 55 years old and above?

"For this research, individuals aged 18 to 55 years are eligible for enrolment based on the specified age requirements."

Answered by AI

Has the Double Blind component of Part B received approval from the FDA?

"The safety rating for Part B: Double Blind is noted to be at level 1 by our team at Power. This assessment aligns with the early Phase 1 nature of this trial, indicating a requirement for further data on both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants

2024. "A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06270511.

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