A Phase 1 interventional study of Setanaxib in Phase 1, sponsored by Calliditas Therapeutics AB. Completed at 1 site in France. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Calliditas Therapeutics AB · Phase 1, Interventional, and Other
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).
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). The study will include 2 parts conducted in separate cohorts of subjects.
Calliditas Therapeutics AB is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single oral dose of 400 mg Setanaxib administered as 1x400 mg tablet in fasting conditions.
Drug: Setanaxib
Single oral dose of 800 mg Setanaxib administered as 2x400 mg tablet in fasting conditions.
Drug: Setanaxib
Single oral dose of 1200 mg Setanaxib administered as 3x400 mg tablet in fasting conditions.
Drug: Setanaxib
Single oral dose of 1600 mg Setanaxib administered as 4x400 mg tablet in fasting conditions.
Drug: Setanaxib
Repeated 10-Day dosing of 1200mg/day of Setanaxib administered as 2x400mg tablet in the morning and as 1x400mg tablet in the evening in fedding conditions.
Drug: Setanaxib
Repeated 10-Day dosing of 1600mg/day of Setanaxib administered as 2x400mg tablet in the morning and as 2x400mg tablet in the evening in fedding conditions.
Drug: Setanaxib
Repeated 10-Day dosing of 1600mg/day of Setanaxib administered as 2x400mg tablet in the morning and as 2x400mg tablet in the evening in fedding conditions. Additionnaly, this cohort includes the evaluation of potential Drug-Drug interactions with CYPs and transporters.
Drug: Setanaxib
Nox 1/4 inhibitor
Also known as: GKT137831
Dose proportionality of setanaxib tablets after single oral administration of different doses.
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.
Time frame: 144 hours
Drug-drug interactions of multiple oral administrations of setanaxib with 5 drugs that interact with CYP3A4, OAT1, OAT3, 2C9 and 2C19.
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).
Time frame: 14 days
Assessment of safety after multiple oral administration of different doses of setanaxib.
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.
Time frame: 10 days
Assessment of safety after single oral administration of different doses of setanaxib.
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.
Time frame: 144 hours
Dose proportionality of setanaxib tablets after multiple oral administration of different doses.
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.
Time frame: 10 days
Plan to share: Undecided
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Calliditas Therapeutics AB