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Pharmacokinetics of Zelquistinel in Fasted or Fed State

NCT07099989 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-03-20

No results posted yet for this study

Summary

The primary purpose of this study is to assess the effect of food on the rate and extent of absorption of a single dose of Zelquistinel 3 mg or 10 mg oral tablets tablets in healthy adult volunteers.

Conditions

  • Healthy Volunteers in Fed and Fasted State

Interventions

DRUG

Zelquistinel 3 mg

Subjects will receive Zelquistinel 3 mg in fed and fasted state (high fat meal).

DRUG

Zelquistinel 10 mg

Subjects will receive Zelquistinel 10 mg in fed and fasted state (high fat meal).

Sponsors & Collaborators

  • Dr. Vince Clinical Research

    collaborator OTHER

  • Syndeio Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Ronald Burch Burch, MD, PhD · Syndeio Biosciences, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2026-02-05
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099989 on ClinicalTrials.gov