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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04351165




Registration number
NCT04351165
Ethics application status
Date submitted
15/04/2020
Date registered
17/04/2020
Date last updated
30/03/2021

Titles & IDs
Public title
BA Study of IMP4297 (20mg vs 10mg) in Healthy Male Subjects
Scientific 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
Secondary ID [1] 0 0
IMP4297-107
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IMP4297

Experimental: Arm 1 - 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.

Experimental: Arm 2 - 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.


Treatment: Drugs: IMP4297
IMP4297 10mg/capsule; IMP4297 20mg/capsule;

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cmax - peak concentration
Timepoint [1] 0 0
3 months
Primary outcome [2] 0 0
AUC0-last - area under the curve from time zero to the time with the last quantifiable concentration
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
AUC0-inf - area under the curve from time zero to infinity
Timepoint [3] 0 0
3 months
Secondary outcome [1] 0 0
Safety endpoints - Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Tmax - time to reach Cmax
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
t½ - elimination half-life
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
CL/F - apparent clearance
Timepoint [4] 0 0
3 months
Secondary outcome [5] 0 0
Vz/F - apparent volume of distribution
Timepoint [5] 0 0
3 months

Eligibility
Key inclusion criteria
1. Healthy male subjects, 18 to 55 years of age (both inclusive) on the day of signing
informed consent form (ICF).

2. Body Mass Index (BMI) of 18 to 30 kg/m2 (both inclusive); and a total body weight 50
kg.

3. 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.

4. 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.

5. 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.

6. Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. 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).

2. Any condition possibly affecting drug absorption (e.g., gastrectomy, difficulty in
swallowing).

3. General anesthesia within 3 months before administration, or have a planned surgery
during the study period.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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).

10. 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.

11. 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).

12. 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.

13. Unable to abstain from strenuous exercise within 48 hours prior to dosing and during
the study period.

14. 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.

15. History of sensitivity to any ingredients of IMP4297 products evaluated in this study.

16. History of hemophobia, inability to tolerate venipuncture, and being afraid of
needles.

17. Subjects who have received live vaccine within 28 days prior to screening.

18. 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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Syneos Health - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Impact Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/show/NCT04351165
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications