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A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions

NCT05665283 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-02-20

No results posted yet for this study

Summary

This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules manufactured by two different processes.

Conditions

  • Bioequivalency

Interventions

DRUG

Ensartinib Hydrochloride

oral ALK inhibitor

Sponsors & Collaborators

  • Xcovery Holdings, Inc.

    lead INDUSTRY

Principal Investigators

  • Giovanni Selvaggi, MD · Xcovery Holdings, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2022-11-29
Primary Completion
2023-01-18
Completion
2023-08-08
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 NCT05665283 on ClinicalTrials.gov