Trials / Completed
CompletedNCT02473627
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Daiichi Sankyo · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DS-1971a | 200mg tablet |
| DRUG | midazolam hydrochloride | 2.5mg oromucosal liquid |
| DRUG | Omeprazole | 20mg gastro-resistant capsule |
| DRUG | Pioglitazone hydrochloride | 15mg tablet |
| DRUG | Buproprion | 150mg Prolonged release tablet |
| DRUG | Tolbutamide | 500mg tablet |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2015-07-01
- Completion
- 2015-07-01
- First posted
- 2015-06-16
- Last updated
- 2015-11-05
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02473627. Inclusion in this directory is not an endorsement.