Healthy VolunteersPhase 1NCT03644576
Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate
A Phase 1 study testing ozanimod and Pseudoephedrine in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of ozanimod after repeated dosing on blood pressure and heart rate response to a single-dose administration of pseudoephedrine (PSE) in healthy adult subjects. Study Design This is a Phase 1, randomized, double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ozanimod and Pseudoephedrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2018to 12 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a man or non-pregnant, non-lactating woman, aged 18 to 55 years, inclusive, at the time of signing the informed consent form (ICF).
- Female subjects must meet at least 1 of the following criteria:
- Negative serum pregnancy test at Screening and Day -2 (women of child-bearing potential [WOCBP] only).
- Postmenopausal (defined as 2 years after the last period and follicle-stimulating hormone [FSH] > 40 IU/L).
- Received surgical sterilization (eg, bilateral tubal ligation, bilateral oophorectomy, hysterectomy) at least 6 months before Screening with medical records.
- Females of child-bearing potential:
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- Must agree to practice a highly effective method of contraception throughout the study until completion of the 75-day Safety Follow-up. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
- Acceptable methods of birth control in this study are the following:
- Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, implantable
- Placement of an intrauterine device or intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence
- Male subjects:
- Must agree to use a latex condom with spermicide during sexual contact with WOCBP while participating in the study and until completion of the 75-day Safety Follow-up.
- All subjects:
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
- Male subjects must agree to refrain from donating sperm during the study and until completion of the 75-day Safety Follow-up.
- Subject has a body weight of at least 110 pounds (50 kg); body mass index (BMI) within the range of 18.0 to 30.0 kg/m2, inclusive, at Screening and Day -2.
- Subject is in good health, as determined by no clinically significant findings from medical or surgical history, 12-lead ECG, physical examination, clinical laboratory tests, and vital signs.
- Subject has a mean systolic blood pressure (SBP) of 90 to 140 mmHg, a diastolic blood pressure (DBP) of 50 to 90 mmHg from three consecutive measurements at Screening and Day -2.
- Subject must be able to comprehend and provide written informed consent, and must be able to comply with the requirements of the study, including the study visit schedule and other protocol requirements
Who cannot join
- Subject has clinically significant electrocardiogram (ECG) and cardiovascular symptoms at Screening.
- Subject has a presence or history of any abnormality or illness that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the study drugs or would limit the subject's ability to participate in and complete this clinical study.
- Subject has a history of clinically significant or unstable vascular disease, or a history of syncope associated with hypotension within the last 2 years or a history of orthostatic hypotension (or SBP decrease of ≥ 20 mmHg 2 minutes after standing compared with supine SBP).
- Subject with a seated pulse rate outside 55 to 90 beats per minute (bpm) at Screening or Day -2.
- Subject with a resting Fridericia-corrected interval between Q and T wave in the heart's electrical cycle (QTcF) > 450 msec (males) or > 470 msec (females) or interval from the beginning of the P wave to the beginning of the QRS complex (PR) > 200 msec at Screening.
- Subject has a history of alcoholism, drug abuse, or addiction within 24 months prior to Screening.
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- Subject has a positive serum test for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at Screening.
- Subject has used any tobacco- or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, vape, electronic cigarettes, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 3 months prior to the first dose of IP.
- Subject has consumed any marijuana products within 3 months prior to the first dose of IP.
- Subject has a positive urine drug test including cotinine at Screening or Day -2.
- Subject has a positive alcohol urine or breath test at Screening or Day -2.
- Subject has received any investigational drug within 30 days or 5 times the elimination half-life (if known), whichever is longer, prior to the first dose of IP.
- Subject has used any systemic over-the-counter medication (excluding acetaminophen up to 1 g/day), dietary or herbal supplement (excluding vitamins/multi-vitamins) within 7 days prior to the first dose of IP. St. John's wort must be discontinued at least 28 days prior to the first dose of IP.
- Subject has used any systemic prescription medication (excluding hormonal contraceptives) within 28 days or 5 times the elimination half-life, whichever is longer, prior to the first dose of IP.
- Subject has used any known MAO inhibitors within 90 days prior to the first dose of IP. 16. Subject has a history of allergic reaction to pseudoephedrine or ozanimod.
- 17. Subject has ingested alcohol within 7 days prior to the first dose of IP. 18. Subject plans or will participate in strenuous physical activities during the 24-hour period prior to the first dose of IP.
- 19. Subject has poor peripheral venous access. 20. Subject has donated greater than 400 mL of blood within 60 days prior to the first dose of IP.
- 21. Subject has a history of any medical history that, in the opinion of the investigator, might confound the results of the study or jeopardize the safety or welfare of the subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Effect of Ozanimod on Blood Pressure and Heart Rate Response to Pseudoephedrine in Healthy Adult Subjects
The purpose of this study is to evaluate the effect of ozanimod after repeated dosing on blood pressure and heart rate response to a single-dose administration of pseudoephedrine (PSE) in healthy adult subjects.
Study Design This is a Phase 1, randomized, double-blind, placebo-controlled study. Approximately sixty eligible subjects will be enrolled and randomized in a 1:1 fashion with 30 subjects in each treatment group.
Read more
Subjects will receive placebo or ozanimod once daily (QD) for 30 days. On Day 30, a single oral dose of pseudoephedrine (PSE) 60 mg will be co-administered with placebo or ozanimod.
Study Population The study will enroll approximately 60 healthy men and non-pregnant, non-lactating women, ages 18 to 55 years, inclusive, with a body weight of at least 110 pounds (50 kg) and body mass index within the range of 18.0 to 30.0 kg/m2, inclusive.
Length of Study The study duration is 65 ± 2 days.
- Conditions
- Healthy Volunteers
- Being tested
- ozanimod, Pseudoephedrine, ozanimod placebo
- Keywords
- Ozanimod, Pseudoephedrine, Healthy Adult Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozanimodDrug
ozanimod
PseudoephedrineDrug
Pseudoephedrine
ozanimod placeboDrug
ozanimod placebo
| Study group | Role | What they receive |
|---|---|---|
| ozanimod plus Pseudophedrine | Experimental | ozanimod once daily (QD) for 30 days. On Day 30, a single dose of pseudoephedrine 60mg will be co-administered with ozanimod. Receives: Drug: ozanimod; Drug: Pseudoephedrine |
| ozanimod placebo plus Pseudoephedrine | Placebo comparator | ozanimod placebo once daily (QD) for 30 days. On Day 30, a single dose of pseudoephedrine 60mg will be co-administered with ozanimod placebo. Receives: Drug: Pseudoephedrine; Drug: ozanimod placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular analysis
Day 30 maximum time-matched change from Day 29 in systolic blood pressure (SBP)
Measured: Days 29 and 30
Secondary outcomes (18)
Pharmacokinetics- Cmax
Maximum observed plasma concentration within dosing interval on Days 1, 5, 8, and 28 for ozanimod and its metabolites, and on Day 30 for pseudoephedrine.
Measured: up to 30 days
Pharmacokinetics- Cmin
Minimum observed plasma concentration within the dosing interval
Measured: up to 30 days
Pharmacokinetics- Tmax
Time to Cmax on Days 1, 5, 8, and 28 for ozanimod, and its metabolites, and on Day 30 for pseudoephedrine.
Measured: up to 30 days
Pharmacokinetics- AUC0-24
Area under the concentration-time curve from time 0 to 24 hours on Days 1, 5, 8, and 28 for ozanimod, its metabolites, total drug and total active drug, and on Day 30 for pseudoephedrine.
Measured: up to 30 days
Pharmacokinetics- Ctrough
Pre- dose or trough concentration for ozanimod and its metabolites on Days 26-30
Measured: up to 30 days
Adverse events (AEs)
Number of participants with adverse events
Measured: up to 30 days
Pharmacokinetics- % total drug related AUC0-24 for each analyte
% total drug related AUC0-24 for ozanimod and each metabolite
Measured: up to 30 days
Pharmacokinetics- % total active drug related AUC0-24 for each active analyte
% total active drug related AUC0-24 for ozanimod and each active metabolite
Measured: up to 30 days
Cardiovascular analysis for DBP
Day 30 maximum time-matched change from Day 29 in diastolic blood pressure (DBP)
Measured: Days 29 and 30
Cardiovascular analysis for heart rate
Day 30 maximum time-matched change from Day 29 in heart rate (HR)
Measured: Days 29 and 30
Cardiovascular analysis for blood pressure
Day 30, 24-hour average change from Day 29 24-hour average in Blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Measured: Days 29 and 30
Cardiovascular analysis for heart rate
Day 30, 24-hour average change from Day 29 24-hour average in Heart rate
Measured: Days 29 and 30
Cardiovascular analysis for blood pressure
Day 29 and Day 30 24-hour average for blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP))
Measured: Days 29 and 30
Cardiovascular analysis for heart rate
Day 29 and Day 30 24-hour average for heart rate
Measured: Days 29 and 30
Cardiovascular analysis for blood pressure
Day 30 time-matched changes from Day 29 for blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP))
Measured: Days 29 and 30
Cardiovascular analysis for heart rate
Day 30 time-matched changes from Day 29 for heart rate
Measured: Days 29 and 30
Cardiovascular analysis for blood pressure
Observed blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP))
Measured: Days 29 and 30
Cardiovascular analysis for Heart Rate
Observed heart rate (HR)
Measured: Days 29 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start11 Jul 2018
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Tran, Pharm.D, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644576
- Sponsor's protocol ID
- RPC01-1914
- Other IDs
- U1111-1215-6267
- Status last verified
- May 2019
- First submitted
- 3 Aug 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tran JQ, Zhang P, Walker S, Ghosh A, Syto M, Wang X, Harris S, Palmisano M. Multiple-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites and the Pharmacodynamic and Pharmacokinetic Interactions with Pseudoephedrine, a Sympathomimetic Agent, in Healthy Subjects. Adv Ther. 2020 Dec;37(12):4944-4958. doi: 10.1007/s12325-020-01500-0. Epub 2020 Oct 6.
PubMed 33025342
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Effect of Ozanimod on Blood Pressure and Heart Rate Response to Pseudoephedrine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03644576
- Acronym / sponsor ID
- RPC01-1914
- Conditions
- Healthy Volunteers
- Keywords
- Ozanimod, Pseudoephedrine, Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of ozanimod after repeated dosing on blood pressure and heart rate response to a single-dose administration of pseudoephedrine (PSE) in healthy adult subjects.
Study Design This is a Phase 1, randomized, double-blind, placebo-controlled study. Approximately sixty eligible subjects will be enrolled and randomized in a 1:1 fashion with 30 subjects in each treatment group.
Subjects will receive placebo or ozanimod once daily (QD) for 30 days. On Day 30, a single oral dose of pseudoephedrine (PSE) 60 mg will be co-administered with placebo or ozanimod.
Study Population The study will enroll approximately 60 healthy men and non-pregnant, non-lactating women, ages 18 to 55 years, inclusive, with a body weight of at least 110 pounds (50 kg) and body mass index within the range of 18.0 to 30.0 kg/m2, inclusive.
Length of Study The study duration is 65 ± 2 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozanimod plus Pseudophedrine | Experimental | Drug: ozanimod, Drug: Pseudoephedrineozanimod once daily (QD) for 30 days. On Day 30, a single dose of pseudoephedrine 60mg will be co-administered with ozanimod. |
| ozanimod placebo plus Pseudoephedrine | Placebo comparator | Drug: Pseudoephedrine, Drug: ozanimod placeboozanimod placebo once daily (QD) for 30 days. On Day 30, a single dose of pseudoephedrine 60mg will be co-administered with ozanimod placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Subject is a man or non-pregnant, non-lactating woman, aged 18 to 55 years, inclusive, at the time of signing the informed consent form (ICF).
- Female subjects must meet at least 1 of the following criteria:
- Females of child-bearing potential:
- Must agree to practice a highly effective method of contraception throughout the study until completion of the 75-day Safety Follow-up. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
- Must agree to use a latex condom with spermicide during sexual contact with WOCBP while participating in the study and until completion of the 75-day Safety Follow-up.
Key exclusion criteria (18 listed)
- Subject has clinically significant electrocardiogram (ECG) and cardiovascular symptoms at Screening.
- Subject has a presence or history of any abnormality or illness that, in the opinion of the investigator, may affect absorption, distribution, metabolism, or elimination of the study drugs or would limit the subject's ability to participate in and complete this clinical study.
- Subject has a history of clinically significant or unstable vascular disease, or a history of syncope associated with hypotension within the last 2 years or a history of orthostatic hypotension (or SBP decrease of ≥ 20 mmHg 2 minutes after standing compared with supine SBP).
- Subject with a seated pulse rate outside 55 to 90 beats per minute (bpm) at Screening or Day -2.
- Subject with a resting Fridericia-corrected interval between Q and T wave in the heart's electrical cycle (QTcF) > 450 msec (males) or > 470 msec (females) or interval from the beginning of the P wave to the beginning of the QRS complex (PR) > 200 msec at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozanimodozanimod | Drug | ozanimod plus Pseudophedrine |
| PseudoephedrinePseudoephedrine | Drug | ozanimod placebo plus Pseudoephedrine, ozanimod plus Pseudophedrine |
| ozanimod placeboozanimod placebo | Drug | ozanimod placebo plus Pseudoephedrine |
Primary outcome
Cardiovascular analysis
Time frame: Days 29 and 30
Day 30 maximum time-matched change from Day 29 in systolic blood pressure (SBP)
18 secondary outcomes
Pharmacokinetics- Cmax
Time frame: up to 30 days
Pharmacokinetics- Cmin
Time frame: up to 30 days
Pharmacokinetics- Tmax
Time frame: up to 30 days
Pharmacokinetics- AUC0-24
Time frame: up to 30 days
Pharmacokinetics- Ctrough
Time frame: up to 30 days
Adverse events (AEs)
Time frame: up to 30 days
Pharmacokinetics- % total drug related AUC0-24 for each analyte
Time frame: up to 30 days
Pharmacokinetics- % total active drug related AUC0-24 for each active analyte
Time frame: up to 30 days
Cardiovascular analysis for DBP
Time frame: Days 29 and 30
Cardiovascular analysis for heart rate
Time frame: Days 29 and 30
Cardiovascular analysis for blood pressure
Time frame: Days 29 and 30
Cardiovascular analysis for heart rate
Time frame: Days 29 and 30
Cardiovascular analysis for blood pressure
Time frame: Days 29 and 30
Cardiovascular analysis for heart rate
Time frame: Days 29 and 30
Cardiovascular analysis for blood pressure
Time frame: Days 29 and 30
Cardiovascular analysis for heart rate
Time frame: Days 29 and 30
Cardiovascular analysis for blood pressure
Time frame: Days 29 and 30
Cardiovascular analysis for Heart Rate
Time frame: Days 29 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Derived from this study: PubMed 33025342Tran JQ, Zhang P, Walker S, Ghosh A, Syto M, Wang X, Harris S, Palmisano M. Multiple-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites and the Pharmacodynamic and Pharmacokinetic Interactions with Pseudoephedrine, a Sympathomimetic Agent, in Healthy Subjects. Adv Ther. 2020 Dec;37(12):4944-4958. doi: 10.1007/s12325-020-01500-0. Epub 2020 Oct 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Tran, Pharm.D study director
Celgene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ozanimod and Pseudoephedrine in people with Healthy Volunteers, run by Celgene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular analysis (time frame: Days 29 and 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.