HealthyPhase 1NCT02989467
Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying
A Phase 1 study testing Aprepitant in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
This research study is being done to compare the effects of Aprepitant and placebo on fasting gastric volume, accommodation volume, satiation (fullness) and gastric emptying. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2017to 1 Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written consent
- No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
- Body Mass Index of 18-35 kg/m^2
- Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure
- For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study
- Female subjects unable to bear children must have this documented in the medical record (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period])
Who cannot join
- Diagnosis of gastrointestinal diseases
- Structural or metabolic diseases that affect the gastrointestinal system
- Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:
- Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin
- Analgesic drugs including NSAIDs and cyclooxygenase-2 (COX-2) inhibitor. (NOTE: Stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible.)
- History of recent surgery (within 60 days of screening).
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- Acute or chronic illness or history of illness, which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
- Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the investigator.
- Acute GI illness within 48 hours of initiation of the baseline period.
- Females who are pregnant or breastfeeding.
- History of excessive alcohol use or substance abuse.
- Participation in an investigational study within the 30 days prior to dosing in the present study.
- Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Single-Center, Placebo-Controlled, Double-Blind Study to Evaluate the Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers
This research study is being done to compare the effects of Aprepitant and placebo on fasting gastric volume, accommodation volume, satiation (fullness) and gastric emptying.
- Conditions
- Healthy
- Being tested
- Aprepitant, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprepitantDrug
Also called Emend
Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.
PlaceboDrug
Subjects will receive one placebo tablet daily for 5 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Aprepitant | Active comparator | Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet. Receives: Drug: Aprepitant |
| Placebo | Placebo comparator | Subjects will receive one placebo tablet daily for 5 consecutive days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Emptying Half-Time of Solids as Measured by Scintigraphy
The time for half of the ingested solids to leave the stomach.
Measured: Day 3, approximately 2 hours after radiolabeled meal is ingested
Satiation Expressed as Volume to Fullness
Subjects will do a satiation/nutrient drink test, consuming Ensure at a relatively constant rate of 30 ml/min. Subjects will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 3.
Measured: Day 4, approximately 30 minutes after liquid meal
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
Subjects will arrive to the Clinical Research and Trials Unit (CRTU) fasting. A radioactive marker will be administered intravenously. After a 10-15 minute wait period a fasting scan will be acquired using a dual-head gamma camera.
Measured: Day 5, approximately 15 minutes after radioactive marker is administered
Postprandial Gastric Volume as Measured by SPECT
At the completion of the fasting scan, the subject will consume 300 ml of Ensure followed by a postprandial scan using a dual-head gamma camera.
Measured: Day 5, approximately 30 minutes after liquid meal
Accommodation Volume as Measured by SPECT
This variable is calculated as postprandial gastric volume minus fasting volume.
Measured: Day 5, approximately 30 minutes after liquid meal
Secondary outcomes (7)
Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours
On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 2 hours.
Measured: Day 3, approximately 2 hours after radiolabeled meal is ingested
Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours
On Day 3, subjects will take part in a gastric emptying by scintigraphy test. Subjects will be given a scrambled egg breakfast with toast and a glass of milk. The eggs and milk contain a small amount of radioactive substance. At the completion of the meal, subjects will stand in front of a special camera and pictures were taken at specific intervals. This outcome measure is the proportion of the radiolabeled meal emptied at 4 hours.
Measured: Day 3, approximately 4 hours after radiolabeled meal is ingested
Maximum Tolerated Volume on Satiation Test
On Day 4, subjects will do a satiation/nutrient drink test. Participants will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 5.
Measured: Day 4, approximately 30 minutes after liquid meal
Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test
Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end.
Measured: Day 4, approximately 30 minutes after liquid meal
Aggregate Symptoms Score
Postprandial symptoms of nausea, bloating, fullness, and pain will be measured using 100 mm horizontal visual analog scales, with the words "none" and "worst ever" anchored at each end. The aggregate symptoms score is calculated by adding the mean individual scores. The lowest possible score would be 0 (none) and the highest maximum score possible is 400 (worst ever).
Measured: Day 4, approximately 1 hour after liquid meal
Gastric Volume Ratio
Postprandial/fasting gastric volume
Measured: Day 5, approximately 1 hour after radioactive marker is administered
Absolute postprandial gastric volume
This is the total postprandial gastric volume
Measured: Day 5, approximately 1 hour after radioactive marker is administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start27 Jan 2017
- Primary completion20 Nov 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989467
- Sponsor's protocol ID
- 16-007929
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2016
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Placebo-Controlled, Double-Blind Study to Evaluate the Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02989467
- Acronym / sponsor ID
- 16-007929
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 12 Dec 2016 (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 research study is being done to compare the effects of Aprepitant and placebo on fasting gastric volume, accommodation volume, satiation (fullness) and gastric emptying.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aprepitant | Active comparator | Drug: AprepitantSubjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive one placebo tablet daily for 5 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to provide written consent
- No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
- Body Mass Index of 18-35 kg/m^2
- Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure
- For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study
Key exclusion criteria (13 listed)
- Diagnosis of gastrointestinal diseases
- Structural or metabolic diseases that affect the gastrointestinal system
- Unable to avoid the following over-the-counter medications 48 hours prior to the baseline period and throughout the study:
- History of recent surgery (within 60 days of screening).
- Acute or chronic illness or history of illness, which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
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 |
|---|---|---|
| AprepitantAlso: EmendSubjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet. | Drug | Aprepitant |
| PlaceboSubjects will receive one placebo tablet daily for 5 consecutive days. | Drug | Placebo |
Primary outcome
Gastric Emptying Half-Time of Solids as Measured by Scintigraphy
Time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested
The time for half of the ingested solids to leave the stomach.
Satiation Expressed as Volume to Fullness
Time frame: Day 4, approximately 30 minutes after liquid meal
Subjects will do a satiation/nutrient drink test, consuming Ensure at a relatively constant rate of 30 ml/min. Subjects will record their sensations every 5 minutes using a numerical scale from 0-5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal, and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation). This measure is the volume consumed when the fullness sensation reaches level 3.
Fasting Gastric Volume as Measured by Single Photon Emission Computed Tomography (SPECT)
Time frame: Day 5, approximately 15 minutes after radioactive marker is administered
Subjects will arrive to the Clinical Research and Trials Unit (CRTU) fasting. A radioactive marker will be administered intravenously. After a 10-15 minute wait period a fasting scan will be acquired using a dual-head gamma camera.
Postprandial Gastric Volume as Measured by SPECT
Time frame: Day 5, approximately 30 minutes after liquid meal
At the completion of the fasting scan, the subject will consume 300 ml of Ensure followed by a postprandial scan using a dual-head gamma camera.
Accommodation Volume as Measured by SPECT
Time frame: Day 5, approximately 30 minutes after liquid meal
This variable is calculated as postprandial gastric volume minus fasting volume.
7 secondary outcomes
Solid Gastric Emptying: Proportion of Meal Emptied at 2 Hours
Time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested
Solid Gastric Emptying: Proportion of Meal Emptied at 4 Hours
Time frame: Day 3, approximately 4 hours after radiolabeled meal is ingested
Maximum Tolerated Volume on Satiation Test
Time frame: Day 4, approximately 30 minutes after liquid meal
Individual Symptom Scores (Nausea, Bloating, Fullness, Pain) on Satiation Test
Time frame: Day 4, approximately 30 minutes after liquid meal
Aggregate Symptoms Score
Time frame: Day 4, approximately 1 hour after liquid meal
Gastric Volume Ratio
Time frame: Day 5, approximately 1 hour after radioactive marker is administered
Absolute postprandial gastric volume
Time frame: Day 5, approximately 1 hour after radioactive marker is administered
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 12 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Michael Camilleri principal investigator
Mayo Clinic
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 Aprepitant in people with Healthy, run by Mayo Clinic 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 6 inclusion and 13 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 12 Dec 2018. 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?
Gastric Emptying Half-Time of Solids as Measured by Scintigraphy (time frame: Day 3, approximately 2 hours after radiolabeled meal is ingested). The study lists 5 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 12 Dec 2018.