Clinical Trials Logo

Clinical Trial Summary

The trial is an open-label, 2-period, single-sequence assessment of CYP3A4 inhibition by aramchol using the probe substrates midazolam and atorvastatin to assess CYP3A4 activity.


Clinical Trial Description

Enrolment of 16 subjects is planned. Each subject will take part in 2 study periods.

In Period 1, subjects will receive a single oral dose of 2 mg midazolam on Day 1 and a single oral dose of 40 mg atorvastatin on Day 3.

In Period 2, subjects will receive twice-daily oral doses of 300 mg aramchol (the IMP) for 18 days. During aramchol dosing, subjects will take a single dose of 2 mg midazolam in the morning on Day 10 and 40 mg atorvastatin in the morning on Day 12.

Subjects will be screened within 21 days before their first dose of study medicine. In Period 1, they will remain resident on the ward from Day -1 to Day 10. In Period 2, subjects will be admitted on Day -1 and discharged on Day 19. Subjects will attend a follow-up visit approximately 2 weeks later, on Day 33 (±2 days). There will be an interval of at least 1 day between Periods 1 and 2. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03760848
Study type Interventional
Source Galmed Pharmaceuticals Ltd
Contact
Status Completed
Phase Phase 1
Start date November 12, 2018
Completion date February 2, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1