Pharmacokinetics and Safety of 'CG-745 IV' and 'CG-750' in Healthy Male Adults
NCT ID: NCT05345912
Last Updated: 2022-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2019-12-16
2021-05-19
Brief Summary
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Detailed Description
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\[Cohort 1\] 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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1
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.
CG-745 IV Solution
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 capsule
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 Placebo
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 saline
IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
Cohort 2
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.
CG-745 IV Solution
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 capsule
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 Placebo
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 saline
IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
Cohort 3
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.
CG-745 IV Solution
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 capsule
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 Placebo
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 saline
IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
Interventions
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CG-745 IV Solution
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 capsule
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 Placebo
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 saline
IV Placebo: 0.9 % normal saline Administered intravenously, once, approximately 9 AM local time in fasted condition, over 60 min infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
19 Years
50 Years
ALL
Yes
Sponsors
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CrystalGenomics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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SeungHwan Lee, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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CG200750-1-01
Identifier Type: -
Identifier Source: org_study_id
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