Solid TumorPhase 1NCT04351165
BA Study of IMP4297 (20mg vs 10mg) in Healthy Male Subjects
A Phase 1 study testing IMP4297 in people with Solid Tumor, run by Impact Therapeutics, Inc. at 1 site in Australia.
Trial summary
An open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (20 mg capsules and 10 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IMP4297
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Oct 2020to 30 Apr 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, 18 to 55 years of age (both inclusive) on the day of signing informed consent form (ICF).
- Body Mass Index (BMI) of 18 to 30 kg/m2 (both inclusive); and a total body weight 50 kg.
- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure (BP), pulse rate (PR) measurement, temperature, 12-lead ECG, or clinical laboratory tests, etc., judged by the investigator. For example, the reference normal ranges (inclusive) are as follows: after at least 5-minute rest in a supine position, BP: 90-139/60-89 mmHg, and PR: 50-100 bpm. Repeat assessment can be conducted at the discretion of the investigator or delegate.
- Subjects able to father children must use a highly effective non-drug contraception double barrier method for the duration of the study and for at least 90 days after the last dose of study medication and should not have any plan for sperm donation throughout this period. Note: Sexual abstinence is allowed if this is the preferred and usual lifestyle of the subject. Male subjects are also eligible to participate if they have a bilateral vasectomy or have a female partner of non-childbearing potential.
- Subjects must voluntarily participate in this study. Be willing and be able to provide written informed consent for this clinical trial. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant diseases, including but not limited to neurologic, cardiovascular, hematological, immunological, renal, hepatic, gastrointestinal, pulmonary, endocrine, metabolic, psychiatric, or allergic disease (including drug and food allergies).
- Any condition possibly affecting drug absorption (e.g., gastrectomy, difficulty in swallowing).
- General anesthesia within 3 months before administration, or have a planned surgery during the study period.
- History of drug abuse within the past 5 years, or a positive urine drug test at screening or the admission. Repeat assessment can be conducted at the discretion of the investigator or delegate.
- History of excessive alcohol intake exceeding 10 drinks/week (1 standard drink = 150 mL of wine, 360 mL of beer, or 45 mL of hard liquor) within 3 months prior to screening, or a positive alcohol breath test at screening or the admission. Repeat assessment can be conducted at the discretion of the investigator or delegate.
- Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day within 3 months prior to screening, a positive urine nicotine test at screening or the admission, or difficulty abstaining from smoking for the duration of study confinement. Repeat assessment can be conducted at the discretion of the investigator or delegate.
Show all 18Show fewer
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug; participation in a clinical trial of device(s) within 30 days prior to the first dose of study drug; participation in ≥4 clinical trials within one year prior to the first dose of study drug.
- Blood donation (excluding plasma donations) or significant loss of blood (≥400 mL) within 1 month prior to screening, received blood transfusion or use of blood products.
- Use of any medicinal product that changes the activity of hepatic enzymes within 28 days prior to the first dose of study drug, such as potent CYP3A4 inhibitors or inducers, or subjects who need to continue receiving these medications during the study period (refer to Appendix 18.2 for the list of common CYP3A4 inhibitors or inducers).
- Use of prescription or nonprescription drugs, dietary supplements, or herbal medicines, within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study drug. As an exception, paracetamol may be used at doses of ≤1 g/day. Limited use of nonprescription medications that are not believed to affect the overall results of the study may be permitted on a case by case basis following approval by the principal investigator and the sponsor.
- Subjects with history of hepatitis, or positive result at screening for hepatitis B surface antigen (HepBsAg), hepatitis B core antibody (HepBcAb), hepatitis C antibody (HCVAb), or human immunodeficiency virus antibody (HIVAb).
- Screening supine 12-lead ECG demonstrating a QTcF (using Fridericia's formula, QTcF = QT/RR1/3) interval >450 msec, or a QRS interval >120 msec. If QTcF >450 msec or QRS >120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the subject's eligibility.
- Unable to abstain from strenuous exercise within 48 hours prior to dosing and during the study period.
- Use of products containing alcohol, tobacco, nicotine, caffeine within 48 hours prior to dosing; or unable to abstain from using these products for the duration of study confinement.
- History of sensitivity to any ingredients of IMP4297 products evaluated in this study.
- History of hemophobia, inability to tolerate venipuncture, and being afraid of needles.
- Subjects who have received live vaccine within 28 days prior to screening.
- Any other medical or psychiatric condition that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study to Compare the Bioavailability of Two IMP4297 Formulations (20 mg Capsules and 10 mg Capsules) After Single Oral Administration of 100 mg IMP4297 Under Fasted Condition in Healthy Male Subjects
An open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (20 mg capsules and 10 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects
Read the detailed description
This will be an open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (10 mg capsules and 20 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects. It will be conducted at one site, and approximately a total of 18 subjects will be enrolled.
Subjects will be randomized to one of the 2 treatment sequences according to a computer-generated randomization schedule. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each period.
- Conditions
- Solid Tumor
- Being tested
- IMP4297
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMP4297Drug
IMP4297 10mg/capsule; IMP4297 20mg/capsule;
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Period 1:
100 mg oral dose of IMP4297 (5 capsules, 20 mg/capsule);
Period 2:
100 mg oral dose of IMP4297 (10 capsules, 10 mg/capsule);
Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each Dose. Receives: Drug: IMP4297 |
| Arm 2 | Experimental | Period 1:
100 mg oral dose of IMP4297 (10 capsules, 10 mg/capsule);
Period 2:
100 mg oral dose of IMP4297 (5 capsules, 20 mg/capsule);
Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each Dose. Receives: Drug: IMP4297 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
peak concentration
Measured: 3 months
AUC0-last
area under the curve from time zero to the time with the last quantifiable concentration
Measured: 3 months
AUC0-inf
area under the curve from time zero to infinity
Measured: 3 months
Secondary outcomes (5)
Safety endpoints
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: 3 months
Tmax
time to reach Cmax
Measured: 3 months
t½
elimination half-life
Measured: 3 months
CL/F
apparent clearance
Measured: 3 months
Vz/F
apparent volume of distribution
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start29 Oct 2020
- Primary completion11 Feb 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Impact Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351165
- Sponsor's protocol ID
- IMP4297-107
- Status last verified
- Aug 2021
- First submitted
- 15 Apr 2020
- Last updated
- 24 Aug 2021
- 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 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study to Compare the Bioavailability of Two IMP4297 Formulations (20 mg Capsules and 10 mg Capsules) After Single Oral Administration of 100 mg IMP4297 Under Fasted Condition in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04351165
- Acronym / sponsor ID
- IMP4297-107
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Impact Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 17 Apr 2020 (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.
An open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (20 mg capsules and 10 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects
Detailed description
This will be an open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (10 mg capsules and 20 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects. It will be conducted at one site, and approximately a total of 18 subjects will be enrolled.
Subjects will be randomized to one of the 2 treatment sequences according to a computer-generated randomization schedule. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: IMP4297Period 1: 100 mg oral dose of IMP4297 (5 capsules, 20 mg/capsule); Period 2: 100 mg oral dose of IMP4297 (10 capsules, 10 mg/capsule); Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each Dose. |
| Arm 2 | Experimental | Drug: IMP4297Period 1: 100 mg oral dose of IMP4297 (10 capsules, 10 mg/capsule); Period 2: 100 mg oral dose of IMP4297 (5 capsules, 20 mg/capsule); Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each Dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male subjects, 18 to 55 years of age (both inclusive) on the day of signing informed consent form (ICF).
- Body Mass Index (BMI) of 18 to 30 kg/m2 (both inclusive); and a total body weight 50 kg.
- Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure (BP), pulse rate (PR) measurement, temperature, 12-lead ECG, or clinical laboratory tests, etc., judged by the investigator. For example, the reference normal ranges (inclusive) are as follows: after at least 5-minute rest in a supine position, BP: 90-139/60-89 mmHg, and PR: 50-100 bpm. Repeat assessment can be conducted at the discretion of the investigator or delegate.
- Subjects able to father children must use a highly effective non-drug contraception double barrier method for the duration of the study and for at least 90 days after the last dose of study medication and should not have any plan for sperm donation throughout this period. Note: Sexual abstinence is allowed if this is the preferred and usual lifestyle of the subject. Male subjects are also eligible to participate if they have a bilateral vasectomy or have a female partner of non-childbearing potential.
- Subjects must voluntarily participate in this study. Be willing and be able to provide written informed consent for this clinical trial. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Key exclusion criteria (18 listed)
- Evidence or history of clinically significant diseases, including but not limited to neurologic, cardiovascular, hematological, immunological, renal, hepatic, gastrointestinal, pulmonary, endocrine, metabolic, psychiatric, or allergic disease (including drug and food allergies).
- Any condition possibly affecting drug absorption (e.g., gastrectomy, difficulty in swallowing).
- General anesthesia within 3 months before administration, or have a planned surgery during the study period.
- History of drug abuse within the past 5 years, or a positive urine drug test at screening or the admission. Repeat assessment can be conducted at the discretion of the investigator or delegate.
- History of excessive alcohol intake exceeding 10 drinks/week (1 standard drink = 150 mL of wine, 360 mL of beer, or 45 mL of hard liquor) within 3 months prior to screening, or a positive alcohol breath test at screening or the admission. Repeat assessment can be conducted at the discretion of the investigator or delegate.
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 |
|---|---|---|
| IMP4297IMP4297 10mg/capsule; IMP4297 20mg/capsule; | Drug | Arm 1, Arm 2 |
Primary outcome
Cmax
Time frame: 3 months
peak concentration
AUC0-last
Time frame: 3 months
area under the curve from time zero to the time with the last quantifiable concentration
AUC0-inf
Time frame: 3 months
area under the curve from time zero to infinity
5 secondary outcomes
Safety endpoints
Time frame: 3 months
Tmax
Time frame: 3 months
t½
Time frame: 3 months
CL/F
Time frame: 3 months
Vz/F
Time frame: 3 months
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 24 Aug 2021.
- 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 IMP4297 in people with Solid Tumor, run by Impact Therapeutics, Inc. at 1 site in Australia.
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 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: finished, as of the sponsor's last update on 24 Aug 2021. 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 Australia. 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 (time frame: 3 months). The study lists 3 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 24 Aug 2021.