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
Status Completed
Phase Phase 1
Start date November 12, 2018
Completion date February 2, 2019

See also
  Status Clinical Trial Phase
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Completed NCT03662100 - A Study of Two Formulations of LY3074828 in Healthy Participants Phase 1
Recruiting NCT02875301 - Investigating Gains in Neurocognition in an Intervention Trial of Exercise Phase 3
Completed NCT03656952 - A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers Phase 1
Completed NCT03670082 - Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State Phase 1
Completed NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A
Completed NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A
Completed NCT03677375 - Hemodilution Validation of INVSENSOR00026 N/A
Recruiting NCT03114839 - Effect of Lactobacillus Casei Shirota on the Small Intestinal Microbiota (ROBIN) N/A
Completed NCT03259464 - This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated Phase 1
Completed NCT03224702 - First-in-Human Trial of Anti-ADAMTS-5 Nanobody in Healthy Volunteers Phase 1
Completed NCT03309566 - Bioequivalence Study of Two Formulatiosns With the Asscociaton of Efavirenz, Emtricitabine and Tenofovir Phase 4
Completed NCT00527579 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [F-18]FB Phase 1
Completed NCT00526916 - PET Imaging of Peripheral Benzodiazepine Receptors in Patients With Neurocysticercosis Using [C-11]PBR28 Phase 1
Not yet recruiting NCT03807973 - Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes. Phase 1
Recruiting NCT03713268 - Intraoperative OCT Guidance of Intraocular Surgery II
Completed NCT03373162 - Functional Effects of Botox on the Brain Using MRS and fMRI Phase 4