Trials / Completed
CompletedNCT03432793
Drug-Drug Interaction (DDI) Study for TD-9855
A Phase 1, Fixed-Sequence, Open-Label Drug-Drug Interaction Study to Assess the Effect of Fluvoxamine (CYP1A2 Inhibitor), Cigarette Smoking (CYP1A2 Inducer) and Itraconazole (CYP3A4 Inhibitor) on the Pharmacokinetics of TD-9855 in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Theravance Biopharma · Industry
- Sex
- Male
- Age
- 19 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to assess the effect of fluvoxamine, itraconazole and smoking on the PK disposition of multiple doses TD-9855 in healthy male subjects. The study will also assess the relationship between caffeine PK and TD-9855 PK disposition in healthy male smokers and non-smokers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TD-9855 | oral tablet, QD |
| DRUG | Fluvoxamine | oral tablet, QD |
| DRUG | Itraconazole | oral tablet solution, QD |
| DRUG | Caffeine | oral solution, single dose |
Timeline
- Start date
- 2018-02-28
- Primary completion
- 2018-04-21
- Completion
- 2018-04-21
- First posted
- 2018-02-14
- Last updated
- 2021-01-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03432793. Inclusion in this directory is not an endorsement.