Hematologic MalignancyPhase 1NCT05716919
Multiple Ascending Dose Study of CG200745 'Ivaltinostat' Oral Capsule
A Phase 1 study testing Ivaltinostat in people with Hematologic Malignancy and Solid Tumor, run by Machaon Biotherapeutics, Inc. at 1 site in South Korea.
Trial summary
A Phase I, Double blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'CG-745' Capsule in Healthy Male Volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancy, Solid Tumor, Fibrosis
- What is being tested?
- Ivaltinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Mar 2023to Dec 2023
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are between 19 to 50 years of age at screening visit.
- Patients who have body weight between 50.0 to 90.0 kg, and Body Mass Index (BMI) of 18.0 to 30.0 kg/m2 at screening visit.
- ☞ BMI (kg/m2) = Body Weight (kg) / {Height(m)}2
- Patients who have signed informed consent prior to study participation after receiving detailed information on the purpose and details of the study, the characteristics of the test drug, and the expected adverse events.
- Patients who are determined to be eligible by the investigator after evaluation of the following screening results: study questionnaires, physical examination, laboratory test, electrocardiogram, vital signs).
Who cannot join
- Medical history of clinically significant hepatic, renal, neurological, respiratory, endocrine, hematological, oncological, cardiovascular, urinary, and/or psychiatric disorder.
- History of gastrointestinal disease or gastrointestinal surgery (except for simple appendectomy or hernia operation) that may affect the pharmacokinetic and/or safety evaluation of IP medications.
- Known clinically significant hypersensitivity to HDAC inhibitors and/or other drugs.
- Systolic blood pressure (SBP) less than 90 mmHg or over 140 mmHg; diastolic blood pressure (DBP) less than 50 mmHg or over 95 mmHg; pulse rate less than 45/min or over 100/min in the sitting position after a 5-minute rest.
- Patients who show one or more of the following findings during screening (including additional tests):
- AST (GOT) or ALT (GPT) exceeds 1.5 times the upper limit of the normal range ② Total bilirubin exceeds 1.5 times the upper limit of the normal range ③ Absolute neutrophil count (ANC) lower than 2,000/uL ④ Hb less than 12.5 g/dL ⑤ Platelets count less than 130,000/uL
Show all 18Show fewer
- Participation in another clinical study or bioequivalence study within 180 days prior to the first IP administration.
- Positive result in serum tests (hepatitis B, hepatitis C, human immunodeficiency virus, and syphilis).
- Donation of whole blood within 60 days, apheresis within 30 days, or transfusion within 30 days prior to the first IP administration.
- Exposure to prescribed medications or herbal medicines 2 weeks prior to the first IP administration, or any general medication (OTC drug), health supplements, and/or vitamin supplements within 1 week prior to the first investigational product administration (the subject may still participate if the principal investigator determines that the subject is eligible for enrollment).
- History of heavy smoking (more than 10 cigarettes/day) within three months prior to the first IP administration, or positive test result in urine cotinine test.
- Excessive caffeine intake (> 5 units/day, 1 unit = 100 mg), excessive alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking during admission period.
- Inability to use a medically acceptable contraceptive method* for the duration of the study and up to 3 months after the last IP administration.
- Medically acceptable contraception:
- Use of intrauterine device (by spouse or partner) with a proven pregnancy prevention rate.
- Concomitant use of barrier method (male or female) and spermicide.
- Patient's or partner's surgery (vasectomy, salpingectomy, tubal ligation, or hysterectomy).
- Patients who are determined to be ineligible to participate in the study by the principal investigator due to other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double Blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'Ivaltinostat' Capsule in Healthy Male Volunteers
A Phase I, Double blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'CG-745' Capsule in Healthy Male Volunteers
- Conditions
- Hematologic Malignancy, Solid Tumor, Fibrosis
- Being tested
- Ivaltinostat, Placebo
- Medical subject headings
- Hematologic Neoplasms, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvaltinostatDrug
Ivaltinostat capsule
PlaceboOther
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - 4 | Experimental | Cohort 1 : 50 mg/day Cohort 2 : 100 mg/day Cohort 3: 200mg/day [Cohort 4: 300mg/day: based on the result of Safety Review Meeting (SRM)] Receives: Drug: Ivaltinostat |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Pharmacokinetic measures (Cmax, Cmax-ss)
Measured: up to 4 weeks
Plasma Pharmacokinetic measures (AUC max, AUCmax-ss)
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 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 posted8 Feb 2023
- Study start9 Mar 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Machaon Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716919
- Sponsor's protocol ID
- CG200745-1-02
- Status last verified
- Oct 2023
- First submitted
- 30 Jan 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double Blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'Ivaltinostat' Capsule in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT05716919
- Acronym / sponsor ID
- CG200745-1-02
- Conditions
- Hematologic Malignancy, Solid Tumor, Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Machaon Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Feb 2023 (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 Phase I, Double blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'CG-745' Capsule in Healthy Male Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - 4 | Experimental | Drug: IvaltinostatCohort 1 : 50 mg/day Cohort 2 : 100 mg/day Cohort 3: 200mg/day [Cohort 4: 300mg/day: based on the result of Safety Review Meeting (SRM)] |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who are between 19 to 50 years of age at screening visit.
- Patients who have body weight between 50.0 to 90.0 kg, and Body Mass Index (BMI) of 18.0 to 30.0 kg/m2 at screening visit.
- ☞ BMI (kg/m2) = Body Weight (kg) / {Height(m)}2
- Patients who have signed informed consent prior to study participation after receiving detailed information on the purpose and details of the study, the characteristics of the test drug, and the expected adverse events.
- Patients who are determined to be eligible by the investigator after evaluation of the following screening results: study questionnaires, physical examination, laboratory test, electrocardiogram, vital signs).
Key exclusion criteria (18 listed)
- Medical history of clinically significant hepatic, renal, neurological, respiratory, endocrine, hematological, oncological, cardiovascular, urinary, and/or psychiatric disorder.
- History of gastrointestinal disease or gastrointestinal surgery (except for simple appendectomy or hernia operation) that may affect the pharmacokinetic and/or safety evaluation of IP medications.
- Known clinically significant hypersensitivity to HDAC inhibitors and/or other drugs.
- Systolic blood pressure (SBP) less than 90 mmHg or over 140 mmHg; diastolic blood pressure (DBP) less than 50 mmHg or over 95 mmHg; pulse rate less than 45/min or over 100/min in the sitting position after a 5-minute rest.
- Patients who show one or more of the following findings during screening (including additional tests):
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 |
|---|---|---|
| IvaltinostatIvaltinostat capsule | Drug | Cohort 1 - 4 |
| PlaceboPlacebo capsule | Other | Placebo |
Primary outcome
Plasma Pharmacokinetic measures (Cmax, Cmax-ss)
Time frame: up to 4 weeks
Plasma Pharmacokinetic measures (AUC max, AUCmax-ss)
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 for each dosing cohort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ivaltinostat in people with Hematologic Malignancy and Solid Tumor, run by Machaon Biotherapeutics, 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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Plasma Pharmacokinetic measures (Cmax, Cmax-ss) (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 23 Oct 2023.