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Anti-metabolites

Modified release formulation of decitabine and tetrahydrouridine for Healthy Subjects

Phase 1

Recruiting

Led By Ingela Danielsson, MD

Research Sponsored by EpiDestiny, 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 0 to 24 hours

Awards & highlights

Study Summary

This trial tests the effectiveness of a modified release combo drug vs. two separate immed. release drugs for treating a medical condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0 to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0 to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 24 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Decitabine and tetrahydrouridine drug level exposure over 24 hr

Peak decitabine and tetrahydrouridine concentration in plasma

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Modified release formulation of decitabine and tetrahydrouridineExperimental Treatment2 Interventions

A modified-release combination formulation of decitabine/THU (2.5 mg/100 mg per capsule given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water.

Group II: Immediate release capsules of decitabine and tetrahydrouridineActive Control2 Interventions

Capsules of THU are given as a single oral dose with approximately 240 mL (8 fluid ounces) of ambient temperature water, followed by a single oral dose of decitabine given 1 hour (± 5 min) later with approximately 240 mL (8 fluid ounces) of ambient temperature water.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2004

Completed Phase 3

~1680

Tetrahydrouridine

2007

Completed Phase 1

~30

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

EpiDestiny, Inc.Lead Sponsor

3 Previous Clinical Trials

82 Total Patients Enrolled

Worldwide Clinical TrialsOTHER

61 Previous Clinical Trials

14,377 Total Patients Enrolled

Ingela Danielsson, MDPrincipal InvestigatorWorldwide Clinical Trials

1 Previous Clinical Trials

24 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 individuals in their 30s eligible for enrollment into this investigation?

"Eligibility for this study requires that patients are between 18 and 50 years old."

Answered by AI

What potential adverse effects can be expected from the Modified release formulation of decitabine and tetrahydrouridine?

"Because the Modified release formulation of decitabine and tetrahydrouridine is currently undergoing Phase 1, there is only a limited amount of clinical evidence to support its safety and efficacy. Therefore, our team at Power has designated it as a '1' on a scale from 1 to 3."

Answered by AI

Are there any specific criteria for who should sign up for this experimental research?

"Candidates aged between 18 and 50 that are in general good health may be eligible for this medical trial. This study is seeking 10 participants in total."

Answered by AI

Are researchers enrolling participants in this clinical research at present?

"Per clinicaltrials.gov, this investigation is actively recruiting participants since it was first advertised on March 24th, 2023 and its details were updated as recently as April 14th of the same year."

Answered by AI

How many individuals have signed up to take part in this experiment?

"Affirmative, the information on clinicaltrials.gov indicates that enrollment is currently underway for this medical trial, which was first unveiled March 24th 2023. The last update to the study was April 14th 2023 and there are 10 positions available across a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males

2023. "To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05816356.