Trials / Completed
CompletedNCT03916406
THE EFFECT OF MULTIPLE DOSES OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL MIDAZOLAM DOSE IN HEALTHY PARTICIPANTS
A PHASE 1, RANDOMIZED, OPEN LABEL, 2-WAY CROSSOVER STUDY TO EVALUATE THE EFFECT OF REPEATED DOSING OF PF-06835919 ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF MIDAZOLAM IN HEALTHY PARTICIPANTS
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase 1, randomized, open label, 2 way crossover drug drug interaction (DDI) study which will evaluate the impact of PF 06835919 on midazolam pharmacokinetics in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of approximately 10 healthy male and/or female participants will be enrolled in this study so that approximately 5 participants will be enrolled into each treatment sequence. In this crossover study, 2 treatments are being assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF 06835919 | 300 mg |
| DRUG | Midazolam | 7.5 mg |
Timeline
- Start date
- 2019-04-18
- Primary completion
- 2019-06-25
- Completion
- 2019-06-25
- First posted
- 2019-04-16
- Last updated
- 2019-07-16
Locations
1 site across 1 country: Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03916406. Inclusion in this directory is not an endorsement.