Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult … (NCT04978298) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants
United States128 participantsStarted 2021-07-19
Plain-language summary
This is a Phase 1, randomized, double-blind, placebo-controlled, active-controlled, comparator controlled, multi-dose, parallel-group study divided into three treatment periods and a follow-up period with five treatment groups. This study will be conducted at 1 clinical research unit (CRU) in the United States (US).
Period 1 will consist of daily escalating doses of tyramine administered until tyramine pressor response (defined as the tyramine dose required to increase systolic blood pressure by at least 30 mm Hg from the daily defined baseline in 3 consecutive measurements within 4 hours after tyramine dosing) is achieved or Day 7.
Participants who achieve tyramine pressor response at tyramine doses \>/= 200mg and \</= 700mg are eligible for continuation into Period 2 and will be randomized accordingly.
Depending on the group to which a participant is randomized, participants will receive rasagiline, phenelzine, ozanimod (therapeutic dose), ozanimod (supra-therapeutic dose), or placebo in Period 2. The duration of dosing depends on the group to which a participant is randomized.
In Period 3, all participants will undergo a sham tyramine challenge and receive a single dose of tyramine placebo. Participants who do not achieve tyramine pressor response following the sham challenge will continue with the tyramine challenge (ie, tyramine pressor tests) for up to 12 additional days.
Participants who receive at least one dose of study drug in Period 2 will participate in a follow-up phase during which 2 follow-up telephone calls will be performed, the last of which will occur approximately 80 to 100 days after the last dose of study drug.
Who can participate
Age range25 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be a male or non-pregnant, non-lactating female, 25 to 55 years of age, inclusive, at the time of signing the informed consent form.
✓. Must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted.
✓. Is willing and able to adhere to the study visit schedule and other protocol requirements.
✓. Female participant must meet at least 1 of the following criteria:
✓. Female of child-bearing potential:
✓. Has a body weight of at least 110 pounds (50 kg); body mass index within the range of 18.0 to 30.0 kg/m2, inclusive.
✓. Is in good health, as determined by no clinically significant findings from medical or surgical history, 12-lead ECG, PE, clinical laboratory safety tests, and vital signs.
✓. Has a mean systolic blood pressure (SBP) of 90 to 139 mm Hg, a diastolic blood pressure (DBP) of 50 to 89 mm Hg from three consecutive measurements at Screening and Day -1.
✕. an unstable SBP (ie, SBP exceeds a maximum range of 15 mm Hg between the lowest and highest values in three consecutive measurements within 15 minutes during Screening).
✕. the presence or history of any clinically relevant abnormality, condition, or disease (such as glaucoma, liver disease or abnormal liver function tests, cardiovascular or pulmonary diseases) that, in the opinion of the Investigator, may affect absorption, distribution, metabolism, or elimination of the IPs, that would prevent the participant from participating in the study, or which places the participant at unacceptable risk if he/she were to participate in the study.
✕. any condition that confounds the ability to interpret data from the study.
✕. history of bipolar, depression or suicidal ideation or behavior, or a history of psychiatric illnesses.
✕. history of clinically significant or unstable vascular disease, a history of syncope associated with hypotension within the last 2 years, a history of orthostatic hypotension (ie, SBP decrease of \> 20 mm Hg between 2 and 5 minutes after standing compared with supine SBP), or a history of tachycardia or hypertension.
✕. an estimated glomerular filtration rate (eGFR) \< 80 mL/min/1.73 m2 according to the 2009 chronic kidney disease (CKD) epidemiology collaboration (CKD EPI) equation: eGFR = 141 × min(Scr/κ, 1) × max(Scr/κ, 1)-1.209 × 0.993Age × 1.018 \[if female\] × 1.159 \[if African American\] where: Scr is serum creatinine in mg/dL, κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.
✕. a seated heart rate outside 55 to 95 beats per minute at Screening or Day -1.
✕. a resting QTcF \> 450 msec (males) or \> 470 msec (females) or PR interval \> 210 msec at Screening or Day -1 or at additional risk for QT interval prolongation.