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ACT-541478 300 mgWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (9)

Name (Synonyms) Correlation
drug65 ACT-541478 dose E1 Wiki 1.00
drug60 ACT-541478 10 mg Wiki 1.00
drug61 ACT-541478 100 mg Wiki 1.00
drug66 ACT-541478 high or low dose (or placebo) Wiki 1.00
drug62 ACT-541478 1000 mg Wiki 1.00
drug1313 LSALT peptide Wiki 1.00
drug63 ACT-541478 30 mg Wiki 1.00
drug1442 Matching placebo Wiki 0.71
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (5)

Name (Synonyms) Correlation
D058186 Acute Kidney Injury NIH 0.24
D014947 Wounds and Injuries NIH 0.22
D013577 Syndrome NIH 0.11
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0001919 Acute kidney injury HPO 0.24

There is one clinical trial.

Clinical Trials

1 Single-center, Double-blind, Randomized, Placebo-controlled, Three-part, First-in-human, Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-541478 in Healthy Subjects

A study in healthy subjects to investigate the safety and tolerability of ACT-541478 as well as what ACT-541478 does to the body and the way the body takes up, distributes, and gets rid of of ACT-541478

NCT04452006 Healthy Drug: ACT-541478 10 mg Drug: ACT-541478 30 mg Drug: ACT-541478 100 mg Drug: ACT-541478 300 mg Drug: ACT-541478 1000 mg Drug: ACT-541478 high or low dose (or placebo) Drug: ACT-541478 dose E1 Drug: Matching placebo

Primary Outcomes

Measure: Treatment-emergent (serious) AEs

Time: From (first) study treatment administration up to 96 h after last study treatment administration in the corresponding period (if applicable). Total duration: up to 5 days.

Other Outcomes

Measure: Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): Cmax

Time: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.

Measure: Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): tmax

Time: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.

Measure: Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): AUC0-inf

Time: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.

Measure: Plasma PK parameters of ACT-541478 - Part A and B, incl. A3 (fed condition): t½

Time: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.

Measure: Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): Cmax

Time: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.

Measure: Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): tmax

Time: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.

Measure: Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): AUCτ

Time: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.

Measure: Plasma PK parameters of ACT-541478 - Part C, incl. C1 to C3 (adults) and E1 (elderly): t1/2

Time: Blood samples for PK analysis will be taken at various timepoints. Total duration: up to 5 days.

Measure: Specific/additional parameters related to safety and tolerability - Part B

Time: At various timepoints. Total duration: up to 5 days.

No related HPO nodes (Using clinical trials)