Who is sponsoring NCT04601766?

NCT04601766 is sponsored by Asieris Pharmaceuticals (AUS) Pty Ltd..

What drugs are being tested in NCT04601766?

Interventions in NCT04601766: APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2, APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2.

What condition does NCT04601766 study?

NCT04601766 studies Bladder Cancer.

Is NCT04601766 still recruiting?

NCT04601766 is currently completed. Last updated 30 June 2021.

Last reviewed 2021-06-30 · How we verify

NCT04601766

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 30 June 2021

What this trial tests

Phase 1 trial testing APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2 in Bladder Cancer in 12 participants. Completed in 1 February 2021.

Timeline

30 October 2020

Primary endpoint
18 December 2020

1 February 2021

Quick facts

Lead sponsor	Asieris Pharmaceuticals (AUS) Pty Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	30 October 2020
Primary completion	18 December 2020
Estimated completion	1 February 2021
Sites	1 location across Australia

Drugs / interventions tested

APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2 — full drug profile →
APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2 — full drug profile →

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Asieris Pharmaceuticals (AUS) Pty Ltd. — full company profile →

Who can join

Adults 18 to 45, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Amino acid metabolism in health and disease.
Ling ZN, Jiang YF, Ru JN, Lu JH, et al · · 2023 · cited 291× · PMID 37699892 · DOI 10.1038/s41392-023-01569-3

Verify or expand the search:

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04601766 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Asieris Pharmaceuticals (AUS) Pty Ltd.
Last refreshed: 30 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04601766.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing