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

No Placebo-Only Group

Summary

This trial tests a new slow-release pill combining decitabine and THU in healthy volunteers. Decitabine helps treat cancer by affecting DNA, while THU helps it stay in the body longer. Combining these two has shown to improve its effectiveness in reducing tumors and enhancing survival.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decitabine and tetrahydrouridine drug level exposure over 24 hr

Peak decitabine and tetrahydrouridine concentration in plasma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 2

~40