CG-549 Tablet Pharmacokinetics Study

NCT05393856 | Completed Phase 1

• 1 other identifier: CG-549-1-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax) of CG549

  up to 4 weeks

• Area Under the Concentration-Time Curve (AUC) of CG549

  up to 4 weeks

Secondary Outcomes (1)

• The Number of Participants Who Experienced Serious or Non-Serious Adverse Events

  up to 4 weeks

Study Arms (2)

fed state in PART B

EXPERIMENTAL

Drug: CG-549

fasted state in PART B

EXPERIMENTAL

Drug: CG-549

Interventions

CG-549 DRUG

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.

Also known as: PART A and PART B

fasted state in PART B; fed state in PART B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sex:Males and females
• Age:18 to 55 years, inclusive, at screening
• Weight:≥50 kg, at screening
• Body mass index:18.0 to 30.0 kg/m2, inclusive, at screening
• Smoking behavior :Non-smoking or smoking ≤5 cigarettes, 1 cigar, or 1 pipe per day
• Other criteria:Liver enzymes within the normal range and creatine phosphokinase within 2.0 times the normal range

You may not qualify if:

• Previous participation in the current study.
• Employee of PRA or the Sponsor.
• History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month prior to screening.
• Presence or history of esophageal or gastroduodenal ulceration within 1 month prior to screening.
• Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, in the opinion of the Investigator.

Sponsors & Collaborators

• CrystalGenomics, Inc.: lead

Study Sites (1)

PRA Health Sciences (PRA) - Early Development Services (EDS)

Groningen, Netherlands

Location

Study Officials

• Maria Velinova, Ph.D

  PRA Health Sciences (PRA) - Early Development Services (EDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized cross-over study

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: May 26, 2022
• Study Start: September 23, 2019
• Primary Completion: January 20, 2020
• Study Completion: June 30, 2020
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

NL (1)