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CG-549 Tablet Pharmacokinetics Study

Sponsor
CrystalGenomics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05393856
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
9.2
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Part A Part A is an open-label, 3-period, fixed-sequence, escalating dose study in 6 healthy subjects to find a tablet dose that results in a CG-549 exposure that is expected to be safe and potentially efficacious (i.e., within the targeted efficacious exposure range as defined below).

Subjects will receive the following treatments of the tablet formulation of CG-549, in the fed state:

  • Period 1: a single oral dose of 300 mg CG-549 on Day 1.

  • Period 2: a single oral dose of XX mg CG-549 on Day 1. After interim PK evaluation of Period 1, the CG-549 dose of Period 2 will aim at reaching the lower end of the targeted efficacious exposure range.

  • Period 3: a single oral dose of YY mg CG-549 on Day 1. After interim PK evaluation of Period 2, the CG-549 tablet dose of Period 3 will aim at reaching the higher end of the targeted efficacious exposure range.

Doses XX and YY will be multiples of 300 mg and will not exceed 3 times the dose used in the preceding period.

After interim PK evaluation of all periods in Part A, the CG-549 dose and the type of breakfast to be used in Part B will be selected which is anticipated to result in an exposure that is expected to be safe and potentially efficacious.

Part B Part B is an open-label, 2-period, randomized crossover study in 18 healthy subjects to confirm that the selected dose of the tablet formulation of CG-549 results in a CG-549 exposure that is expected to be safe and potentially efficacious, and to compare the PK profiles of a single dose of the tablet formulation of CG 549 between the fed and the fasted states.

Subjects will receive the following treatments of the tablet formulation of CG-549:

  • 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. Dose ZZ will be a multiple of 300 mg.

There will be 2 treatment sequences in the study: fed-fasted and fasted-fed. Subjects will be randomly assigned to a treatment sequence in a 1:1 ratio. In the fed state, subjects will either receive a high-fat or a medium fat breakfast.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized cross-over studyRandomized cross-over study
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CG-549 Tablet Pharmacokinetics Study: An Open-label, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of a Tablet Formulation of CG-549 in Healthy Subjects
Actual Study Start Date :
Sep 23, 2019
Actual Primary Completion Date :
Jan 20, 2020
Actual Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: fed state in PART B

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.
Other Names:
  • PART A and PART B

    		•
    Experimental: fasted state in PART B

    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.
    Other Names:
  • PART A and PART B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of CG549 [up to 4 weeks]

    2. Area Under the Concentration-Time Curve (AUC) of CG549 [up to 4 weeks]

    Secondary Outcome Measures

    1. The Number of Participants Who Experienced Serious or Non-Serious Adverse Events [up to 4 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:

    1. Sex:Males and females

    2. Age:18 to 55 years, inclusive, at screening

    3. Weight:≥50 kg, at screening

    4. Body mass index:18.0 to 30.0 kg/m2, inclusive, at screening

    5. Smoking behavior :Non-smoking or smoking ≤5 cigarettes, 1 cigar, or 1 pipe per day

    6. Other criteria:Liver enzymes within the normal range and creatine phosphokinase within 2.0 times the normal range

    Key Exclusion Criteria:

    1. Previous participation in the current study.

    2. Employee of PRA or the Sponsor.

    3. History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month prior to screening.

    4. Presence or history of esophageal or gastroduodenal ulceration within 1 month prior to screening.

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PRA Health Sciences (PRA) - Early Development Services (EDS) Groningen Netherlands

    Sponsors and Collaborators

    • CrystalGenomics, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CrystalGenomics, Inc.
    ClinicalTrials.gov Identifier:
    NCT05393856
    Other Study ID Numbers:
    • CG-549-1-03
    First Posted:
    May 26, 2022
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 26, 2022