Healthy MalePhase 1NCT05202912
Food Effect Study of IDX-1197 in Healthy Subjects
A Phase 1 study testing IDX-1197(After a meal) and IDX-1197(fasting) in people with Healthy Male, run by Idience Co., Ltd. at 1 site in South Korea.
Trial summary
Study to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian 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
- Healthy Male
- What is being tested?
- IDX-1197(After a meal) and IDX-1197(fasting)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jan 2022to 23 Jul 2022
- 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
- Healthy male Korean, Chinese, or Caucasian adults at the age of ≥19 to ≤50 years old at the time of written informed consent:
- Body weight ≥55.0 kg AND body mass index (BMS) ≥18.0 kg/m2 to <30.0 kg/m2 at screening: BMI(kg/m2) = body weight (kg) / {height (m)}2
- The subject must voluntarily decide to participate in the study after being informed of, and fully understanding, details of the study; written informed consent must be obtained prior to any of the screening procedures.
- Eligible for this study as determined by the investigator based on physical examinations, clinical laboratory tests, and interviews.
Who cannot join
- Evidence or history of clinically significant hepatic, renal, neurological, respiratory, endocrine, blood and tumor, cardiovascular, urinary, and psychiatric disorders.
- Evidence or history of gastrointestinal disorders (gastrointestinal ulcer, gastritis, gastrodynia, gastroesophageal reflux disease, Crohn's disease, etc.) that might affect the safety and PK of IP and/or history of gastrointestinal surgery (except for simple appendectomy and hernia repair).
- Hypersensitivity to drugs or history of any clinically significant hypersensitivity.
- Any of the following screening test results:
- Hemoglobin level < 12.0 g/dL
- Creatinine clearance: <60 mL/min/1.73m2 as calculated by the equation of Modification of Diet in Renal Disease
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- QTc interval: > 450 ms
- Positive serum tests (hepatitis B, hepatitis C, human immunodeficiency virus, syphilis)
- Screening systolic blood pressure <90 mmHg or >150 mmHg and/or diastolic blood pressure <60 mmHg or >100 mmHg as measured in sitting position after ≥3 minutes of rest.
- History of drug abuse or a positive urine screening test for drugs of abuse.
- Prior or expected treatment with any prescription drugs or herbal medicine within 2 weeks and/or any over the counter drugs, health functional foods, or vitamins within 1 week prior to the planned first IP dosing (individuals who are determined to be eligible at the discretion of the investigator based on other criteria will be allowed to participate in the study).
- Treatment with drug metabolizing enzyme inducers and/or suppressors such as barbitals within 1 month prior to the planned first IP dosing.
- Having participated in another clinical trial or a bioequivalence study and administered any IP within 6 months prior to the planned first IP dosing in the present study.
- Whole blood donation within 2 months and/or apheresis donation within 1 month and/or blood transfusion within 1 month prior to the planned first IP dosing.
- Continuous, excessive caffeine intake or continuous alcohol intake or unable to refrain from caffeine/alcohol consumption during hospitalization.
- Current smoker (individuals who stopped smoking 3 months prior may be included in the study) or unable to stop smoking from 3 months prior to the planned first IP dosing to the last hospital discharge.
- Having had any foods containing grapefruits from 24 hours prior to hospital admission to discharge in each period/cohort and/or unable to refrain from having foods containing grapefruits during the same period of time.
- Unable to refrain from having foods containing caffeine (coffee, tea [black tea, green tea, etc.], carbonated drink, coffee milk, nutrients and tonics, etc.) from 24 hours prior to hospital admission to discharge in each period/cohort.
- Individual or his spouse/partner who is unable to use medically acceptable methods of contraception throughout the study plus for at least 3 months from the last IP dosing and who does not agree not to donate sperm during the same period of time.
- Ineligible for study participation in the opinion of the investigator for other reasons including clinical laboratory test results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-dose, Crossover Phase 1 Clinical Trial to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian Volunteers
Study to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian Volunteers
- Conditions
- Healthy Male
- Being tested
- IDX-1197(After a meal), IDX-1197(fasting)
- Keywords
- 1197, IDX-1197, venadaparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDX-1197(After a meal)Drug
randomized, open-label, single-dose, 2-period, 2-sequence crossover study in healthy male Korean and Caucasian volunteers
IDX-1197(fasting)Drug
open-label, single-dose study in Chinese male volunteers
| Study group | Role | What they receive |
|---|---|---|
| Cohort A(Food effect) | Other | Not described Receives: Drug: IDX-1197(After a meal) |
| Cohort B(Single dose) | Other | Not described Receives: Drug: IDX-1197(fasting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of IDX-1197
PK parameters will be assessed using plasma IDX-1197 concentrations measured
Measured: through study completion, an average of 1 year
AUClast of IDX-1197
PK parameters will be assessed using plasma IDX-1197 concentrations measured
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
AUCinf of IDX-1197
PK parameters will be assessed using plasma IDX-1197 concentrations measured
Measured: through study completion, an average of 1 year
Tmax of IDX-1197
PK parameters will be assessed using plasma IDX-1197 concentrations measured
Measured: through study completion, an average of 1 year
t1/2 of IDX-1197
PK parameters will be assessed using plasma IDX-1197 concentrations measured
Measured: through study completion, an average of 1 year
CL/F of IDX-1197
PK parameters will be assessed using plasma IDX-1197 concentrations measured
Measured: through study completion, an average of 1 year
Vd/F of IDX-1197
PK parameters will be assessed using plasma IDX-1197 concentrations measured
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start16 Jan 2022
- Primary completion23 Jul 2022
- Study completion23 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MaleStudies 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
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202912
- Sponsor's protocol ID
- ID-VDP-104
- Status last verified
- Jan 2022
- First submitted
- 16 Dec 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Phase 1 Clinical Trial to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian Volunteers
- ClinicalTrials.gov ID
- NCT05202912
- Acronym / sponsor ID
- ID-VDP-104
- Conditions
- Healthy Male
- Keywords
- 1197, IDX-1197, venadaparib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Idience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2022 (actual)
- Primary completion
- 23 Jul 2022 (actual)
- Study completion
- 23 Jul 2022 (actual)
- First posted
- 24 Jan 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.
Study to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of IDX-1197 After Single Oral Administration in Healthy Male Korean, Chinese, and Caucasian Volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A(Food effect) | Other | Drug: IDX-1197(After a meal) |
| Cohort B(Single dose) | Other | Drug: IDX-1197(fasting) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male Korean, Chinese, or Caucasian adults at the age of ≥19 to ≤50 years old at the time of written informed consent:
- Body weight ≥55.0 kg AND body mass index (BMS) ≥18.0 kg/m2 to <30.0 kg/m2 at screening: BMI(kg/m2) = body weight (kg) / {height (m)}2
- The subject must voluntarily decide to participate in the study after being informed of, and fully understanding, details of the study; written informed consent must be obtained prior to any of the screening procedures.
- Eligible for this study as determined by the investigator based on physical examinations, clinical laboratory tests, and interviews.
Key exclusion criteria (20 listed)
- Evidence or history of clinically significant hepatic, renal, neurological, respiratory, endocrine, blood and tumor, cardiovascular, urinary, and psychiatric disorders.
- Evidence or history of gastrointestinal disorders (gastrointestinal ulcer, gastritis, gastrodynia, gastroesophageal reflux disease, Crohn's disease, etc.) that might affect the safety and PK of IP and/or history of gastrointestinal surgery (except for simple appendectomy and hernia repair).
- Hypersensitivity to drugs or history of any clinically significant hypersensitivity.
- Any of the following screening test results:
- Screening systolic blood pressure <90 mmHg or >150 mmHg and/or diastolic blood pressure <60 mmHg or >100 mmHg as measured in sitting position after ≥3 minutes of rest.
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 |
|---|---|---|
| IDX-1197(After a meal)randomized, open-label, single-dose, 2-period, 2-sequence crossover study in healthy male Korean and Caucasian volunteers | Drug | Cohort A(Food effect) |
| IDX-1197(fasting)open-label, single-dose study in Chinese male volunteers | Drug | Cohort B(Single dose) |
Primary outcome
Cmax of IDX-1197
Time frame: through study completion, an average of 1 year
PK parameters will be assessed using plasma IDX-1197 concentrations measured
AUClast of IDX-1197
Time frame: through study completion, an average of 1 year
PK parameters will be assessed using plasma IDX-1197 concentrations measured
5 secondary outcomes
AUCinf of IDX-1197
Time frame: through study completion, an average of 1 year
Tmax of IDX-1197
Time frame: through study completion, an average of 1 year
t1/2 of IDX-1197
Time frame: through study completion, an average of 1 year
CL/F of IDX-1197
Time frame: through study completion, an average of 1 year
Vd/F of IDX-1197
Time frame: through study completion, an average of 1 year
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 9 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 IDX-1197(After a meal) and IDX-1197(fasting) in people with Healthy Male, run by Idience Co., Ltd. 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 4 inclusion and 20 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 9 Aug 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?
Cmax of IDX-1197 (time frame: through study completion, an average of 1 year). 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 9 Aug 2022.