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CG-549 Tablet Pharmacokinetics Study

NCT05393856 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-05-26

No results posted yet for this study

Summary

This will be an open label, crossover, single dose study consisting of 2 parts (Part A and Part B) in a total of 24 healthy male and female subjects.

Conditions

  • Healthy

Interventions

DRUG

CG-549

PART A (open-label) Period 1: single oral dose. Period 2: After PK evaluation of period 1. Period 3: After PK evaluation of period 2. PART B (randomized) * Period 1: a single oral dose of ZZ mg CG-549 on Day 1 in fed or fasted state. * Period 2: a single oral dose of ZZ mg CG-549 on Day 1 in fasted or fed state.

Sponsors & Collaborators

  • CrystalGenomics, Inc.

    lead INDUSTRY

Principal Investigators

  • Maria Velinova, Ph.D · PRA Health Sciences (PRA) - Early Development Services (EDS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2020-01-20
Completion
2020-06-30

Countries

  • Netherlands

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 NCT05393856 on ClinicalTrials.gov