Healthy VolunteersPhase 1NCT02621385
Study to Assess the Effect of Multiple Doses of Tradipitant on CYP3A4 Using Midazolam as a Substrate in Healthy Subjects
A Phase 1 study testing tradipitant and Midazolam in people with Healthy Volunteers, run by Vanda Pharmaceuticals at 1 site in Switzerland.
Trial summary
This study is designed to evaluate the potential effect of administration of tradipitant on CYP3A4 using midazolam pharmacokinetics as markers. The study will also further characterize the pharmacokinetics of tradipitant. 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?
- tradipitant and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2015to Feb 2016
- 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
- Ability and acceptance to provide written informed consent;
- Subjects must be males or females between 18 and 55 years of age, inclusive;
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum or urine pregnancy test at the Screening visit and at Check-in (Days -1) and agree not to attempt to become pregnant during the course of the study. Female subjects of childbearing potential (including peri-menopausal women who have had a menstrual bleeding within 1 year) must be using appropriate birth control (e.g. intrauterine device [IUD], diaphragm or condom with spermicidal jelly or foam or cervical cap) for a period of 35 days before the first dosing, for the duration of the study, and recommended to use it for one month after the last dose. Women are considered to be not of childbearing potential if they have been surgically sterilized (physician-documented hysterectomy or tubal ligation);
- Note: Women are not permitted to use hormonal methods of birth control (e.g. oral contraceptives, hormonal intrauterine device [IUD], patch and steroids) and must use another acceptable method of birth control during the study and recommended to use it for one month after the last dose. Women currently taking oral contraceptives will be required to discontinue their regimen at least two weeks prior to first dosing.
- Subjects with Body Mass Index (BMI) of ≥18 and ≤33kg/m2 (BMI = weight (kg)/ [height (m)]2);
- Vital signs (after 3 minutes resting in sitting position) which are within the ranges shown below:
Show all 12Show fewer
- Body temperature between 35.0-37.5 °C;
- Systolic blood pressure between 90-150 mmHg;
- Diastolic blood pressure between 50-95 mmHg;
- Pulse rate between 50-100 beats per minute
- Willing and able to comply with study requirements;
- Subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, clinical laboratory tests and urinalysis;
Who cannot join
- History of recent (within six months) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse or evidence of such abuse as indicated by the laboratory assays conducted during the Screening visit or at Check-in;
- Any major surgery within three months of Day 1 or any minor surgery within one month;
- Donation or loss of 400 mL or more of blood within 3 months prior to the Baseline Visit;
- History or current evidence of cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
- Any condition requiring the regular use of medication;
- History of intolerance and/or hypersensitivity to drugs including midazolam, tradipitant, or a medications similar to tradipitant and its accompanying excipients within the past two months prior to Day 1;
Show all 25Show fewer
- History (including family history) or current evidence of congenital long QT syndrome or known acquired QT interval prolongation;
- Subjects who are currently considered at suicide risk, any subject who has ever made a suicide attempt, or those who are currently demonstrating active (within the past 6 months) suicidal ideation as deemed by the Columbia Suicide Severity Rating Scale (C- SSRS);
- History of liver disease and/or positive for one or more of the following serological results:
- a positive hepatitis C antibody test (anti-HCV)
- a positive HIV (ELISA and Western-to confirm positive finding) test result c. positive hepatitis B surface antigen (HBsAg)
- Treatment with any drug known to cause major organ system toxicity (e.g., chloramphenicol or tamoxifen) during the 60 days preceding Day 1;
- Elevated (> 2 times the upper limit of normal) liver function tests (i.e.
- aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), and total bilirubin);
- Inability to be venipunctured and/or tolerate venous access;
- Subjects who have used tobacco products 3 months prior to dosing. Tobacco users will be defined as any subject who reports cigarette, cigar, tobacco, nicotine gum, nicotine patch or electronic cigarette use;
- Consumption of >1 drink/day of alcohol for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2010 ;
- Consumption of >5 cups coffee/tea/day;
- Participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study;
- Use of prescription or OTC medications, including herbal products (e.g., St. John's Wort) within 2 weeks of Day 1;
- Use of any food or beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family (e.g. kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, mustard) and charbroiled meat within 1 week before Day 1;
- Abnormal diets (<1600 or >3500 kcal/day), substantial changes in eating habits in the 4 weeks before this study, or vegetarians;
- Participation in a previous LY686017 or VLY-686/tradipitant trial;
- Anyone affiliated with the site or sponsor and/or anyone who may consent under duress;
- Any other sound medical reason as determined by the clinical Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-sequence Study to Assess the Effect of Multiple Doses of Tradipitant on Cytochrome P450 3A4 Using Midazolam as a Substrate in Healthy Subjects.
This study is designed to evaluate the potential effect of administration of tradipitant on CYP3A4 using midazolam pharmacokinetics as markers.
The study will also further characterize the pharmacokinetics of tradipitant.
- Conditions
- Healthy Volunteers
- Being tested
- tradipitant, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tradipitantDrug
test agent
MidazolamDrug
substrate for drug-drug interaction assessment
| Study group | Role | What they receive |
|---|---|---|
| Tradipitant | Experimental | One dose of midazolam followed by tradipitant dosing for days 3-16. Midazolam is also given on day 16 Receives: Drug: tradipitant; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midazolam Area Under the Curve (AUC)
Measured: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Midazolam time to maximal plasma concentration (Tmax)
Measured: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Midazolam maximal plasma concentration (Cmax)
Measured: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Secondary outcomes (11)
α-hydroxymidazolam area under the curve(AUC)
Measured: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours
α-hydroxymidazolam time to maximal plasma concentration (Tmax)
Measured: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
α-hydroxymidazolam maximal plasma concentration (Cmax)
Measured: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites area under the curve (AUC)
Measured: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites time to maximal plasma concentration (Tmax)
Measured: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites maximal plasma concentration (Cmax)
Measured: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by spontaneous reporting of AEs measured by events related to treatment.
Measured: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal laboratory values
Measured: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal ECG values
Measured: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal vital signs
Measured: 19 days
• The Columbia Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation
Measured: Baseline, Day 10, Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
- Investigators
- Milko Radicioni, MD, Principal investigator, CROSS Research SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621385
- Sponsor's protocol ID
- VP-VLY-686-1102
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-sequence Study to Assess the Effect of Multiple Doses of Tradipitant on Cytochrome P450 3A4 Using Midazolam as a Substrate in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT02621385
- Acronym / sponsor ID
- VP-VLY-686-1102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
This study is designed to evaluate the potential effect of administration of tradipitant on CYP3A4 using midazolam pharmacokinetics as markers.
The study will also further characterize the pharmacokinetics of tradipitant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tradipitant | Experimental | Drug: tradipitant, Drug: MidazolamOne dose of midazolam followed by tradipitant dosing for days 3-16. Midazolam is also given on day 16 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Ability and acceptance to provide written informed consent;
- Subjects must be males or females between 18 and 55 years of age, inclusive;
- Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum or urine pregnancy test at the Screening visit and at Check-in (Days -1) and agree not to attempt to become pregnant during the course of the study. Female subjects of childbearing potential (including peri-menopausal women who have had a menstrual bleeding within 1 year) must be using appropriate birth control (e.g. intrauterine device [IUD], diaphragm or condom with spermicidal jelly or foam or cervical cap) for a period of 35 days before the first dosing, for the duration of the study, and recommended to use it for one month after the last dose. Women are considered to be not of childbearing potential if they have been surgically sterilized (physician-documented hysterectomy or tubal ligation);
- Subjects with Body Mass Index (BMI) of ≥18 and ≤33kg/m2 (BMI = weight (kg)/ [height (m)]2);
- Vital signs (after 3 minutes resting in sitting position) which are within the ranges shown below:
Key exclusion criteria (25 listed)
- History of recent (within six months) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse or evidence of such abuse as indicated by the laboratory assays conducted during the Screening visit or at Check-in;
- Any major surgery within three months of Day 1 or any minor surgery within one month;
- Donation or loss of 400 mL or more of blood within 3 months prior to the Baseline Visit;
- History or current evidence of cardiovascular, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction judged by the Investigator to be clinically significant;
- Any condition requiring the regular use of medication;
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 |
|---|---|---|
| tradipitanttest agent | Drug | Tradipitant |
| Midazolamsubstrate for drug-drug interaction assessment | Drug | Tradipitant |
Primary outcome
Midazolam Area Under the Curve (AUC)
Time frame: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Midazolam time to maximal plasma concentration (Tmax)
Time frame: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Midazolam maximal plasma concentration (Cmax)
Time frame: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
11 secondary outcomes
α-hydroxymidazolam area under the curve(AUC)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours
α-hydroxymidazolam time to maximal plasma concentration (Tmax)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
α-hydroxymidazolam maximal plasma concentration (Cmax)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites area under the curve (AUC)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites time to maximal plasma concentration (Tmax)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites maximal plasma concentration (Cmax)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by spontaneous reporting of AEs measured by events related to treatment.
Time frame: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal laboratory values
Time frame: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal ECG values
Time frame: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal vital signs
Time frame: 19 days
• The Columbia Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation
Time frame: Baseline, Day 10, Day 19
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 27 Apr 2016.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Milko Radicioni, MD principal investigator
CROSS Research SA
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 tradipitant and Midazolam in people with Healthy Volunteers, run by Vanda Pharmaceuticals at 1 site in Switzerland.
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 12 inclusion and 25 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 27 Apr 2016. 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 Switzerland. 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. 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?
Midazolam Area Under the Curve (AUC) (time frame: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2016.