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Bladder CancerPhase 1NCT04601766

A Phase I, Two-phase, Crossover Study to Evaluate the Safety, Tolerability and Pharmacokinetics of APL-1501 ER Tablets

A Phase 1 study testing APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2 and APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2 in people with Bladder Cancer, run by Asieris Pharmaceuticals (AUS) Pty Ltd. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Bladder Cancer
What is being tested?
APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2 and APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteAustralia
Study dates
30 Oct 2020to 1 Feb 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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • The subject is able to communicate well with the researchers and is able to complete the trial in accordance with the protocol
  • 18 to 45 years old (including 18 and 45 years old)
  • Postmenopausal females or sterilized participant must be at least 6 months post-menopausal, surgically sterile; the postmenopausal/sterilization should be confirmed by FSH testing
  • 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)
  • Must have normal organ functions, including the following:
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  • Bone marrow reserve: within normal range or deemed NCS by the treating investigator
  • Hepatic: total bilirubin within normal range or deemed NCS by the treating investigator; aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 1.5x ULN
  • Renal: serum creatinine ≤ ULN Confidential Page 7 of 61
  • Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ ULN or deemed NCS by the treating investigator
  • QTCF≤450 msec for males and 470 msec for females
  • 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)
  • 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)

Who cannot join

  • History of allergy to any research drug components, similar drugs or their excipients
  • History of optic nerve disorder, malignancy, anemia or gastrointestinal, liver and kidney diseases that may affect the pharmacokinetics of the investigational drugs
  • 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)
  • Subject who is positive for urine drug screening or who with a history of drug abuse
  • 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
  • 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
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  • Systemic treatment on any investigational clinical trial within 28 days (or 5 half-lives of that agent, whichever is greater) prior to enrollment
  • 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.
  • Pregnancy or lactation
  • Any other reason that in the opinion of the Investigator or Sponsor would prevent the patient from completing participation or following the study schedule

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Scientia clinical research

    Randwick, New South Wales, 2031

Other trials in Australia

About this study

Official 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

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.

Conditions
Bladder Cancer
Being tested
APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2, APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2Drug

    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)

  • APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2Drug

    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)

Study groups in NCT04601766
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2
Group BExperimentalNot described
Receives: Drug: APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs

    Number of subjects with AEs,

    Measured: 6 months

  2. SAEs

    Number of subjects with SAEs

    Measured: 6 months

Secondary outcomes (6)

  1. PK parameters: area under the curve (AUC)

    Area under the curve (AUC) of APL-1501 ER Tablets, and APL-1202 Tablets

    Measured: 6 months

  2. PK parameters: maximum concentration (Cmax)

    maximum concentration (Cmax), of APL-1501 ER Tablets, and APL-1202 Tablets

    Measured: 6 months

  3. PK parameters: Tmax

    Tmax of APL-1501 ER Tablets, and APL-1202 Tablets

    Measured: 6 months

  4. PK parameters: half-life

    apparent t1/2 of APL-1501 ER Tablets, and APL-1202 Tablets

    Measured: 6 months

  5. Urine concentration

    Urine concentration of APL-1501 ER Tablets 2, APL-1501 ER Tablets 3, and APL-1202 Tablets.

    Measured: 6 months

  6. Accumulated excretion rate (Ae%)

    Accumulated excretion rate (Ae%) of APL-1501 ER Tablets 2, APL-1501 ER Tablets 3, and APL-1202 Tablets.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start30 Oct 2020
  3. Primary completion18 Dec 2020
  4. Study completion1 Feb 2021

Resources

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04601766
Sponsor's protocol ID
YHGT-PN-01
Status last verified
Oct 2020
First submitted
20 Oct 2020
Last updated
30 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2 and APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2 in people with Bladder Cancer, run by Asieris Pharmaceuticals (AUS) Pty Ltd. 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 13 inclusion and 10 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 30 Jun 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?

AEs (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT04601766.

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 30 Jun 2021.

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Clinical Trial NCT04601766 | AzTrials