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14C-DNL343 for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Denali Therapeutics Inc.

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 28 days

Awards & highlights

Study Summary

This trial aims to study how the body absorbs, processes, and gets rid of a drug called DNL343 in healthy male volunteers.

Who is the study for?

This clinical trial is for healthy men aged 18 to 65 with a BMI between 18.0 and 32.0 kg/m2, who have at least one bowel movement per day. Participants must use effective contraception if they're sexually active with women able to bear children.Check my eligibility

What is being tested?

[14C]-DNL343 is being tested in this Phase 1 study to understand how it's absorbed, metabolized, and excreted after a single oral dose given to healthy male participants.See study design

What are the potential side effects?

As this is an early-stage study focusing on absorption and metabolism of the drug in healthy individuals, specific side effects are not detailed but may include typical reactions to new substances such as digestive discomfort or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Extent and rate of recovery of total radioactivity in urine and feces

Total radioactivity in blood-to-plasma ratio

Total radioactivity in plasma and whole blood

Secondary outcome measures

DNL343 and a DNL343 metabolite recoveries in urine

Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)

PK Parameter: AUC0-tlast

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 14C-DNL343Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Denali Therapeutics Inc.Lead Sponsor

22 Previous Clinical Trials

1,860 Total Patients Enrolled

Ana-Claire Meyer, MDStudy DirectorDenali Therapeutics

1 Previous Clinical Trials

47 Total Patients Enrolled

Frequently Asked Questions

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

Has the drug 14C-DNL343 received approval from the FDA?

"For this Phase 1 trial involving 14C-DNL343, our team at Power rates the safety as a level 1 on a scale of 1 to 3. This indicates that there may be limited data available supporting both safety and efficacy at this stage."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, clinicaltrials.gov reports that this ongoing medical trial is actively seeking candidates. The study was originally uploaded on March 1st, 2024 and had its latest update on February 28th of the same year. This investigation aims to recruit a total of seven participants from one designated location."

Answered by AI

Is the research study open to participants who are older than 50 years of age?

"Individuals eligible for participation in this research must be above 18 years of age but below the age of 65."

Answered by AI

Which specific criteria must an individual meet in order to be considered a suitable candidate for enrollment in this research study?

"This clinical investigation aims to enroll 7 healthy volunteers aged between 18 and 65 who meet the subsequent requirements: Being in good physical condition, having a body mass index ranging from 18.0 to 32.0 kg/m2, being male within the age bracket of 18-65 years, implementing highly effective birth control methods when sexually active with women capable of bearing children, and maintaining a history of at least one daily bowel movement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants

2024. "A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06281158.

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