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SetanaxibWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug2192 Point-of-care test for SARS-CoV-2 Wiki 1.00

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 An Open-Label Phase 1 Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects

The study is a monocentric, open label, phase 1 study to evaluate the pharmacokinetics, and in particular the dose proportionality of setanaxib and its metabolites after a single oral dose (400 mg, 800 mg, 1200 mg, and 1600 mg) (Part 1) and after multiple oral doses (Part 2).

NCT04327089 Phase 1 Drug: Setanaxib

Primary Outcomes

Description: Measure the AUC and bioavailability (particularly the dose proportionality) of setanaxib tablets, after single oral administration of different doses (400, 800, 1200 and 1600mg) in healthy adult male and female subjects.

Measure: Dose proportionality of setanaxib tablets after single oral administration of different doses.

Time: 144 hours

Description: Measure the changes in AUC of 5 drugs that interact with CYP3A4, OAT1, OAT3, 2C9 and 2C19 in healthy adult male (8) and female (8) subjects after multiple administrations of Setanaxib at dose of 1600mg only (cohort 6) or 800mg (cohort 7).

Measure: Drug-drug interactions of multiple oral administrations of setanaxib with 5 drugs that interact with CYP3A4, OAT1, OAT3, 2C9 and 2C19.

Time: 14 days

Description: To evaluate the biological, physiological and treatment-related adverse events of setanaxib after multiple oral administration doses up to 1600 mg/day in healthy male and female subjects.

Measure: Assessment of safety after multiple oral administration of different doses of setanaxib.

Time: 10 days

Secondary Outcomes

Description: To evaluate the biological, physiological and treatment-related adverse events of setanaxib tablets after single oral administration of 4 different doses in healthy male and female subjects.

Measure: Assessment of safety after single oral administration of different doses of setanaxib.

Time: 144 hours

Description: Measure the AUC and bioavailability (particularly the dose proportionality) of setanaxib tablets after multiple oral administration at 2 different doses in healthy adult male and female subjects.

Measure: Dose proportionality of setanaxib tablets after multiple oral administration of different doses.

Time: 10 days

No related HPO nodes (Using clinical trials)