HealthyPhase 1NCT05393856
CG-549 Tablet Pharmacokinetics Study
A Phase 1 study testing CG-549 in people with Healthy, run by CrystalGenomics, Inc. at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CG-549
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Sep 2019to 30 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences (PRA) - Early Development Services (EDS)
Groningen
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- CG-549
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-549Drug
Also called PART A and PART B
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.
| Study group | Role | What they receive |
|---|---|---|
| fed state in PART B | Experimental | Not described Receives: Drug: CG-549 |
| fasted state in PART B | Experimental | Not described Receives: Drug: CG-549 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of CG549
Measured: up to 4 weeks
Area Under the Concentration-Time Curve (AUC) of CG549
Measured: up to 4 weeks
Secondary outcomes (1)
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start23 Sep 2019
- Primary completion20 Jan 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over study
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CrystalGenomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Velinova, Ph.D, Principal investigator, PRA Health Sciences (PRA) - Early Development Services (EDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393856
- Sponsor's protocol ID
- CG-549-1-03
- Status last verified
- May 2022
- First submitted
- 10 Dec 2019
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05393856
- Acronym / sponsor ID
- CG-549-1-03
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CrystalGenomics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross-over study
| Arm | Type | Receives |
|---|---|---|
| fed state in PART B | Experimental | Drug: CG-549 |
| fasted state in PART B | Experimental | Drug: CG-549 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG-549Also: PART A and PART BPART 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. | Drug | fasted state in PART B, fed state in PART B |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of CG549
Time frame: up to 4 weeks
Area Under the Concentration-Time Curve (AUC) of CG549
Time frame: up to 4 weeks
1 secondary outcome
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Time frame: up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Velinova, Ph.D principal investigator
PRA Health Sciences (PRA) - Early Development Services (EDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CG-549 in people with Healthy, run by CrystalGenomics, Inc. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of CG549 (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.