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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04601766




Registration number
NCT04601766
Ethics application status
Date submitted
20/10/2020
Date registered
26/10/2020
Date last updated
30/06/2021

Titles & IDs
Public title
A Phase I, Two-phase, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APL-1501 ER Tablets
Scientific title
A Phase I, Open-Label, Randomized, Two-phase, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APL-1501 ER Tablets 2, APL1501 ER Tablets 3, and APL-1202 in Healthy Volunteers
Secondary ID [1] 0 0
YHGT-PN-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bladder Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2
Treatment: Drugs - APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2

Experimental: Group A -

Experimental: Group B -


Treatment: Drugs: APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2
Phase1: Period 1 drug administration( APL-1202 50 mg, 3 tablets, orally );Washout( 7± 1 day) ; Period 2 drug administration(1501 ER Tablets 3 382 mg ASN-1324, 1 tablet); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet)

Treatment: Drugs: APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2
Phase1: Period 1 drug administration( 1501 ER Tablets 3 382 mg ASN-1324, 1 tablet );Washout( 7± 1 day) ; Period 2 drug administration(APL-1202 50 mg, 3 tablets, orally); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AEs
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
SAEs
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
PK parameters: area under the curve (AUC)
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
PK parameters: maximum concentration (Cmax)
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
PK parameters: Tmax
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
PK parameters: half-life
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Urine concentration
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Accumulated excretion rate (Ae%)
Timepoint [6] 0 0
6 months

Eligibility
Key inclusion criteria
1. The subject must have informed consent before the trial, and have a full understanding
of the content, process and possible adverse reactions of the trial, and voluntarily
signed a written informed consent form

2. The subject is able to communicate well with the researchers and is able to complete
the trial in accordance with the protocol

3. 18 to 45 years old (including 18 and 45 years old)

4. Postmenopausal females or sterilized participant must be at least 6 months
post-menopausal, surgically sterile; the postmenopausal/sterilization should be
confirmed by FSH testing

5. The body weight of male subjects are = 50 kg, and that of female subjects are = 45 kg,
and the body mass index (BMI) are between 18.0 and 30.0 kg/m2, including the boundary
value. BMI= weight (kg) / height2 (m2)

6. Must have normal organ functions, including the following:

1. Bone marrow reserve: within normal range or deemed NCS by the treating
investigator

2. Hepatic: total bilirubin within normal range or deemed NCS by the treating
investigator; aspartate transaminase (AST) and/or alanine aminotransferase (ALT)
= 1.5x ULN

3. Renal: serum creatinine = ULN Confidential Page 7 of 61

4. Prothrombin time (PT) and partial thromboplastin time (PTT) = ULN or deemed NCS
by the treating investigator

5. QTCF=450 msec for males and 470 msec for females

7. Healthy as determined by physician, based on a medical evaluation including Physical
examination and vital signs, hematology, biochemistry, coagulation, urinalysis, and
12-lead Electrocardiograms (ECGs)

8. Willingness for subjects of reproductive potential to use highly effective methods of
contraception from the beginning of the study screening to the end of study follow up
period a. A highly effective method of contraception is defined as one that results in
a low failure rate (i.e., less than 1% per year, when used consistently and correctly)
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of allergy to any research drug components, similar drugs or their excipients

2. History of optic nerve disorder, malignancy, anemia or gastrointestinal, liver and
kidney diseases that may affect the pharmacokinetics of the investigational drugs

3. Subject who is positive in one or more of the tests of hepatitis B surface antigen
(HBsAg), hepatitis C antibody (HCV), and AIDS antibody (HIV)

4. Subject who is positive for urine drug screening or who with a history of drug abuse

5. Subject who smoked more than 5 cigarettes per day in the 3 months before the trial,
and/or disagreed to avoid using any tobacco products 24 hours before administration
and during hospitalization

6. Regular drinkers within 6 months before the trial, that is, those who drank more than
14 units of alcohol per week (1 unit = 10 g pure alcohol), and/or those who do not
agree to stop alcohol intake 24 hours before administration and during
hospitalization, and/or positive in breath alcohol test. STANDARD DRINK= Volume of
Alcoholic Drinks x Concentration of Alcoholic Drinks x 0.789/pure alcohol

7. Systemic treatment on any investigational clinical trial within 28 days (or 5
half-lives of that agent, whichever is greater) prior to enrollment

8. Subject who take strong inducers or inhibitors of metabolism enzymes or transporter
within 48 h before the study, including but not limited to caffeine, xanthine,
grapefruit, grapefruit juice or grapefruit-related citrus fruits (e.g. Seville
oranges, pomelos) etc.

9. Pregnancy or lactation

10. Any other reason that in the opinion of the Investigator or Sponsor would prevent the
patient from completing participation or following the study schedule

Study design
Purpose of the study
Treatment
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2021
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia clinical research - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Asieris Pharmaceuticals (AUS) Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A two-phase study design will be used for this pilot study. In the first phase, a 2×2
crossover study will be used to evaluate the safety, tolerability and PK characteristic of
APL-1202 and APL-1501 ER Tablets 3. Twelve healthy subjects will be in ratio 1:1 randomly
assigned to two groups, randomization will be stratified by gender (male, female) in ratio
1:1. Each group will be dosed with APL-1202, APL-1501 ER Tablets 3 in a cross-over way. A
7-day (±1 day) washout will be required before next period of drug administration. The
samples in first phase will be sent to bioanalysis lab for PK research at the end of first
phase. The initiate of second phase will depend on the results of first phase within 30 days
and not less than 7 days after the first phase.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04601766
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