drugset / Trial / NCT02473627
A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTS
Non-randomizedCrossoverOpen-labelBasic science
Summary
This is an open-label, cross-over, fixed-sequence study. All subjects will receive the same treatment in two study periods. The study is designed to test whether DS-1971a has any effect on the activity of various enzymes involved in the metabolism of medicines, using test medications. These will be given without and then with DS-1971a to see if DS-1971a has any effect on the blood levels of the test medicines.
Timeline
- Start
- 2015-05
- Primary completion
- 2015-07
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 150 mg | Oral |
| Subject | DS-1971 | Small molecule | 400 mg | Oral |
| Subject | Midazolam | Small molecule | 2.5 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | Oral |
| Subject | Pioglitazone | Small molecule | 15 mg | Oral |
| Subject | Tolbutamide | Small molecule | 500 mg | Oral |
Indications
No indication recorded.