Clinical Trials Logo
  1. Home
  2. Phase 1
  3. NCT04327089

Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects

Phase 1 Clinical Trial

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

Clinical Trial Summary

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).

Clinical Trial Description

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. - Part 1 of the study will be an open label, single dose study evaluating the pharmacokinetics, and in particular the dose proportionality of setanaxib formulated as tablets, in 4 separate cohorts of 6 to 8 healthy adult subjects - Part 2 of the study will assess the pharmacokinetics of setanaxib tablets, expand the evaluation of potential drug-drug interactions, and assess the safety of setanaxib tablets at doses up to 1600mg/day for 14 days in separate 2 cohorts. The evaluation of drug-drug interactions will be carried out only at the top dose. Accordingly, a larger cohort (i.e. 16 subjects) will be included in Cohort 7. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04327089
Study type Interventional
Source Calliditas Therapeutics AB
Contact
Status Completed
Phase Phase 1
Start date June 24, 2020
Completion date March 23, 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT02010944 - A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels Phase 1
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT05068947 - Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects Phase 1
Completed NCT03273192 - A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects Phase 1
Completed NCT03883620 - Safety Study of Dengushield in Healthy Adults Phase 1
Completed NCT01091532 - A Study In Healthy People Of Multiple Doses Of UK-396,082 Given By Mouth, To Investigate The Safety, Toleration And Time Course Of Blood Concentration Of UK-396,082 And Its Effects. Phase 1
Completed NCT02634489 - EC905 Pharmacokinetic Profile Study Phase 1
Completed NCT03647670 - A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers Phase 1
Completed NCT03488719 - A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate Phase 1
Completed NCT03983876 - PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI) Phase 1
Completed NCT03273088 - Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects Phase 1
Completed NCT03740217 - Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets Phase 1
Recruiting NCT06214858 - The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects Phase 1
Completed NCT04014257 - A Phase 1 Study of NOV1601(CHC2014) in Adult Subjects With Solid Organ Malignancies Phase 1