Clinical TrialID 4963
Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response
NCT03694119
Healthy Volunteer
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 4963
- Evidence Id
- 4963
- Core Evidence Id
- 4963
- Source Clinical Trial Id
- 4943
- Herb2 Clinical Trial Id
- HBCT004943
- Nct Id
- NCT03694119
- Title
- Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response
- Status
- Completed
- Phase
- Phase 1
- Study Result
- No
- Study Condition
- Healthy Volunteer
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
- Intervention
- DRUG: Phenelzine|DRUG: Tyramine|DRUG: Phenelzine placebo|DRUG: ozanimod placebo|DRUG: ozanimod
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Triple
- Intervention Purpose
- Basic_Science
- Gender
- All
- Age
- Adult
- Enrollment
- 92
- Outcome Measure
- Cardiovascular, Tyramine sensitivity factor (TSF) is the ratio of Tyr30 in Period 1 over Tyr30 in Period 3. Tyr30 is defined as the tyramine dose required to increase systolic blood pressure (SBP) by at least 30 mm Hg from daily defined baseline in three consecutive measurements within 4 hours after tyramine dosing., Up to approximately day 49
- Sponsor Collaborator
- Celgene
- Funded By
- INDUSTRY
- Location
- PPD Phase 1 Clinic, Austin, Texas, 78744, United States
- Other Id
- RPC01-1913|U1111-1218-6630
- Start Date
- 2018-07-24
- Primary Completion Date
- 2019-01-08
- Completion Date
- 2019-01-08
- First Posted
- 2018-10-03
- Results First Posted
- Last Update Posted
- 2019-07-19
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT03694119
- Title Cn
- Title En
- Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response
- Bilingual Status
- semi_complete