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single dose of [14C]-HU6 for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Rivus Pharmaceuticals, 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 up to day 29

Awards & highlights

Study Summary

This trial is studying how the body processes a new medication called HU6 when taken with a meal. They will look at how the body absorbs, breaks down, and eliminates the medication, as well

Who is the study for?

Healthy men aged 18 to 55, with a BMI of 18.0-32.5 kg/m2 and weight between 55-100 kg can join this study. They must be in good health as confirmed by medical exams and tests, understand the consent form, agree to use effective contraception methods during the study and for three months after.Check my eligibility

What is being tested?

[14C]-HU6 is being tested in healthy volunteers to see how it's absorbed, metabolized, and excreted after one dose taken with food. This Phase 1 trial will also look at its safety and how the body handles it over time (pharmacokinetics).See study design

What are the potential side effects?

Since [14C]-HU6 is under initial testing in humans, potential side effects are not fully known but may include typical drug-related reactions such as nausea or allergic responses; close monitoring will occur for any adverse effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 29 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To assess the mass balance

Trial Design

1Treatment groups

Experimental Treatment

Group I: single dose of [14C]-HU6Experimental Treatment1 Intervention

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?

Rivus Pharmaceuticals, Inc.Lead Sponsor

7 Previous Clinical Trials

546 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment for this investigation presently open?

"As per the details available on clinicaltrials.gov, this investigation is actively seeking eligible participants. The trial was first listed on March 26th, 2024 and underwent its latest revision on April 16th, 2024."

Answered by AI

Does this study allow individuals who are older than 75 years to participate?

"Individuals seeking to take part in this research must be between 18 and 55 years old."

Answered by AI

What is the current number of participants involved in this clinical investigation?

"Yes, details on clinicaltrials.gov confirm that this trial is actively seeking volunteers. The study was initially listed on 3/26/2024 and last revised on 4/16/2024. It aims to recruit 8 individuals from a single site."

Answered by AI

Has the Food and Drug Administration officially sanctioned a solitary administration of [14C]-HU6?

"The safety evaluation by our team at Power assigns a score of 1 to the single dose administration of [14C]-HU6. This rating is due to the Phase 1 nature of the trial, where there exists minimal data supporting both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6

2024. "A Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-HU6". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06325930.

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