drugset / Trial / NCT03760848
Study of Potential for Drug Interactions Mediated by CYP3A4 Inhibition With Aramchol in Healthy Volunteers
Phase 1
Completed
15 enrolled
Galmed Pharmaceuticals Ltd
Alderley Analytical Ltd. · collabAnalyst Research Laboratories · collabDiamond Pharma Services Regulatory Affairs Consultancy · collabHammersmith Medicines Research · collab
NaSingle-groupOpen-labelOther
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.
Timeline
- Start
- 2018-11-12
- Primary completion
- 2019-02-02
- Completion
- 2019-02-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aramchol | Other / unclassified | 300 mg | Oral |
| Subject | Atorvastatin | Small molecule | 40 mg | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
Indications
No indication recorded.