HealthyPhase 1NCT05345912
Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults
A Phase 1 study testing CG-745 IV Solution and CG-750 125mg capsule in people with Healthy, run by CrystalGenomics, Inc. at 1 site in South Korea.
Trial summary
A randomized, placebo-controlled, dose-escalation, crossover study. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CG-745 IV Solution and CG-750 125mg capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Dec 2019to 19 May 2021
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject who signed voluntarily the written agreement after understanding the purpose, contents, the properties and expected adverse effects of investigational product
- Subject who is considered to be appropriate for the study according to the judgment of investigator based on physical examination, clinical laboratory test, electrocardiogram, vital sign and questionnaire
Who cannot join
- Subject with clinically meaningful and relevant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system and mental system
- Subject with sensitive reaction in HDAC inhibitor or another drug
- Subject who participated in another clinical trial or bioequivalent study with past 6 weeks
- Subject who is not considered to be appropriate for the study according to the judgment of investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled, Dose-escalation, Crossover Study to Compare and Evaluate the Pharmacokinetics and Safety of 'CG-745 IV' Intravenous Formulation and 'CG-750' Capsule Formulation in Healthy Male Adults
A randomized, placebo-controlled, dose-escalation, crossover study.
Read the detailed description
Total of 24 health volunteers will be randomized to receive either of Cohort 1,2 or 3. (8 subjects each)
[Cohort 1] Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated CG-750 capsule or placebo with 150 mL of water.
[Cohort 2] The recommended dose of capsule in cohort 2 will be determined based on the bioavailabilty and safety data of cohort 1.
Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 capsules or placebo with 150 mL of water.
After 2-week rest period, subject will take the high fat diet and then be administrated the determined dose of CG-750 or placebo with 150 mL of water.
[Cohort 3] The recommended dose of capsule in cohort 3 will be determined based on the bioavailabilty of cohort 1 and 2.
Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 or placebo with 150 mL of water.
- Conditions
- Healthy
- Being tested
- CG-745 IV Solution, CG-750 125mg capsule, PO Placebo, IV Placebo: 0.9 % normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-745 IV SolutionDrug
Also called CG200745
CG-745 IV: Supplied as 125 mg/vial Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
CG-750 125mg capsuleDrug
Also called CG200750
CG-750 capsule: Supplied as 125 mg/capsule Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3
PO PlaceboOther
PO Placebo: Supplied as placebo capsule (same appearance as in CG-750 Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3
IV Placebo: 0.9 % normal salineOther
IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects received 125 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 125 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. Receives: Drug: CG-745 IV Solution; Drug: CG-750 125mg capsule; Other: PO Placebo; Other: IV Placebo: 0.9 % normal saline |
| Cohort 2 | Experimental | Subjects received 250 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 375 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. Receives: Drug: CG-745 IV Solution; Drug: CG-750 125mg capsule; Other: PO Placebo; Other: IV Placebo: 0.9 % normal saline |
| Cohort 3 | Experimental | Subjects received 125 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 750 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. Receives: Drug: CG-745 IV Solution; Drug: CG-750 125mg capsule; Other: PO Placebo; Other: IV Placebo: 0.9 % normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration of CG200745 (Cmax)
Plasma level vs. time profiles were plotted for each subject in linear or log/linear graphs.
Measured: 0 (pre-dose), 0.33 (20 min), 0.67 (40 min), 1 (60 min), 1.083 (1h 5 min), 1.25 (1h 15 min), 1.5, 2,3,4,5,6,7,9,12,25,48,72hr after dose
Area Under the Concentration-Time Curve (AUC 0-72h)
Plasma level vs. time profiles were plotted for each subject in linear or log/linear
Measured: 0 (pre-dose), 0.33 (20 min), 0.67 (40 min), 1 (60 min), 1.083 (1h 5 min), 1.25 (1h 15 min), 1.5, 2,3,4,5,6,7,9,12,25,48,72hr after dose
Secondary outcomes (1)
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Measured: Up to 4 weeks for each dosing cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start16 Dec 2019
- Primary completion18 Sep 2020
- Study completion19 May 2021
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
- A randomized, double-blind, placebo-controlled, dose-escalation, crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CrystalGenomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHwan Lee, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345912
- Sponsor's protocol ID
- CG200750-1-01
- Status last verified
- Apr 2022
- First submitted
- 3 Dec 2019
- Last updated
- 26 Apr 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled, Dose-escalation, Crossover Study to Compare and Evaluate the Pharmacokinetics and Safety of 'CG-745 IV' Intravenous Formulation and 'CG-750' Capsule Formulation in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT05345912
- Acronym / sponsor ID
- CG200750-1-01
- 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
- 16 Dec 2019 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 26 Apr 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.
A randomized, placebo-controlled, dose-escalation, crossover study.
Detailed description
Total of 24 health volunteers will be randomized to receive either of Cohort 1,2 or 3. (8 subjects each)
[Cohort 1] Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated CG-750 capsule or placebo with 150 mL of water.
[Cohort 2] The recommended dose of capsule in cohort 2 will be determined based on the bioavailabilty and safety data of cohort 1.
Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 capsules or placebo with 150 mL of water.
After 2-week rest period, subject will take the high fat diet and then be administrated the determined dose of CG-750 or placebo with 150 mL of water.
[Cohort 3] The recommended dose of capsule in cohort 3 will be determined based on the bioavailabilty of cohort 1 and 2.
Subject will fast for at least 10 hours in first treatment, and then be administrated with CG-745 IV or placebo. After 2-week rest period, subject will fast for at least 10 hours in second treatment, and then be administrated the determined dose of CG-750 or placebo with 150 mL of water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, double-blind, placebo-controlled, dose-escalation, crossover study
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CG-745 IV Solution, Drug: CG-750 125mg capsule, Other: PO Placebo, Other: IV Placebo: 0.9 % normal salineSubjects received 125 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 125 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. |
| Cohort 2 | Experimental | Drug: CG-745 IV Solution, Drug: CG-750 125mg capsule, Other: PO Placebo, Other: IV Placebo: 0.9 % normal salineSubjects received 250 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 375 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. |
| Cohort 3 | Experimental | Drug: CG-745 IV Solution, Drug: CG-750 125mg capsule, Other: PO Placebo, Other: IV Placebo: 0.9 % normal salineSubjects received 125 mg of either placebo IV or CG-745 IV infusion over 60 min. After 14 days wash-out period, subjects received 750 mg of either placebo (PO) or CG-750 capsule orally in the fasted state for at least 10 hours. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject who signed voluntarily the written agreement after understanding the purpose, contents, the properties and expected adverse effects of investigational product
- Subject who is considered to be appropriate for the study according to the judgment of investigator based on physical examination, clinical laboratory test, electrocardiogram, vital sign and questionnaire
Key exclusion criteria (4 listed)
- Subject with clinically meaningful and relevant disease in liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, cardiovascular system, urinary system and mental system
- Subject with sensitive reaction in HDAC inhibitor or another drug
- Subject who participated in another clinical trial or bioequivalent study with past 6 weeks
- Subject who is not considered to be appropriate for the study according to the judgment of 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-745 IV SolutionAlso: CG200745CG-745 IV: Supplied as 125 mg/vial Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion | Drug | Cohort 1, Cohort 2, Cohort 3 |
| CG-750 125mg capsuleAlso: CG200750CG-750 capsule: Supplied as 125 mg/capsule Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3 | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PO PlaceboPO Placebo: Supplied as placebo capsule (same appearance as in CG-750 Administered orally, once, approximately 9 AM local time in fasted condition except for fed condition in Cohort 2, period 3 | Other | Cohort 1, Cohort 2, Cohort 3 |
| IV Placebo: 0.9 % normal salineIV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Maximum Observed Plasma Concentration of CG200745 (Cmax)
Time frame: 0 (pre-dose), 0.33 (20 min), 0.67 (40 min), 1 (60 min), 1.083 (1h 5 min), 1.25 (1h 15 min), 1.5, 2,3,4,5,6,7,9,12,25,48,72hr after dose
Plasma level vs. time profiles were plotted for each subject in linear or log/linear graphs.
Area Under the Concentration-Time Curve (AUC 0-72h)
Time frame: 0 (pre-dose), 0.33 (20 min), 0.67 (40 min), 1 (60 min), 1.083 (1h 5 min), 1.25 (1h 15 min), 1.5, 2,3,4,5,6,7,9,12,25,48,72hr after dose
Plasma level vs. time profiles were plotted for each subject in linear or log/linear
1 secondary outcome
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Time frame: Up to 4 weeks for each dosing cohort
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 Apr 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.
SeungHwan Lee, Ph.D principal investigator
Seoul National University Hospital
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-745 IV Solution and CG-750 125mg capsule in people with Healthy, run by CrystalGenomics, Inc. at 1 site in South Korea.
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 2 inclusion and 4 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 Apr 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 South Korea. 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 of CG200745 (Cmax) (time frame: 0 (pre-dose), 0.33 (20 min), 0.67 (40 min), 1 (60 min), 1.083 (1h 5 min), 1.25 (1h 15 min), 1.5, 2,3,4,5,6,7,9,12,25,48,72hr after dose). 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 Apr 2022.