Trials / Terminated
TerminatedNCT03979820
A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure
A Phase I Parallel Group Study in Healthy Subjects to Evaluate the Effect of Multiple Oral Doses of BI 1467335 and Phenelzine as Positive Control on Blood Pressure Response to Oral Tyramine (Double-blind, Randomised, Placebo-controlled Design for BI 1467335 Treatment Groups, Open Label for Phenelzine)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The main objective of the study is investigate the effect of escalating doses of oral tyramine on systolic blood pressure (SBP) at baseline and following an oral treatment with BI 1467335 up to 39 days at a low or high dose once daily compared to placebo and phenelzine (Nardil®) as positive control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 1467335 | Film-coated tablet |
| DRUG | Placebo | Film-coated tablet |
| DRUG | Phenelzine sulfate | Film-coated tablet |
| DRUG | Tyramine | Capsules |
Timeline
- Start date
- 2019-07-31
- Primary completion
- 2020-04-08
- Completion
- 2020-04-08
- First posted
- 2019-06-07
- Last updated
- 2021-06-04
- Results posted
- 2021-06-04
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03979820. Inclusion in this directory is not an endorsement.