PharmacokineticsPhase 1NCT03012763
Oral Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan Using Different Administration Mediums
A Phase 1 study testing Paracetamol, Sulfasalazine and Fexofenadine in people with Pharmacokinetics and Magnetic Resonance Imaging, run by University Medicine Greifswald.
Trial summary
The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine, given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml grapefruit juice prior to ingestion and to… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Magnetic Resonance Imaging, Administration, Oral
- What is being tested?
- Paracetamol, Sulfasalazine and Fexofenadine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jan 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ethnic origin: Caucasian
- body mass index: ≥ 18.5 kg/m² and ≤ 30 kg/m²
- good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
- written informed consent
Who cannot join
- weight less than 45 kg
- claustrophobia
- tinnitus
- cardiac pacemakers, metallic, plastic or silicone implants, dental retainer or metal-containing tattoos and piercings, Permanent Make-Ups, intrauterine devices
- known allergic reactions/ hypersensitivity to the active ingredients used or to constituents of the study medication (e.g. lactose, lecithin, sulfonamides, salicylates)
- bronchial asthma (all stages) and other known allergic diseases
Show all 29Show fewer
- existing cardiac, haematopoietic or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics or the requirements for the magnetic resonance tomography
- known hyperkalemia, hyponatremia or hypovolemia or medications that may cause these conditions.
- Hepatic, renal or metabolic diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication (e.g. liver failure, kidney failure, acute intermittent porphyria).
- gastrointestinal diseases and/or pathological findings, which might interfere with gastrointestinal motility and emptying processes and interfering with pharmacokinetics and pharmacodynamics of the study medication (e.g. ileus)
- Erythema exsudativum multiforme.
- Glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency).
- Acute, chronic or recurrent infections.
- drug or alcohol dependence
- positive drug or alcohol screening
- smokers of 10 or more cigarettes per day
- positive results in HIV, hepatitis B virus and hepatitis C virus screenings
- subjects who are on a diet which could affect gastrointestinal motility or the pharmacokinetics of the drug (vegetarian, vegan)
- eating disorders e.g. anorexia, bulimia
- heavy tea or coffee drinkers (more than 1l per day)
- lactation and/or pregnancy test positive or not performed
- subjects suspected or known not to follow instructions
- subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- subjects liable to orthostatic dysregulation, fainting or blackouts
- participation in a clinical trial during the last 3 months prior to the planned start of the study less than 3 months after last blood donation
- therapy with transdermal patches
- any systemically available medication within 2 weeks prior to the intended first administration unless because of the terminal elimination half-life complete elimination from the body can be assumed for the drug and/or its primary metabolites (except oral contraceptives)
- intake of grapefruit or poppy seeds containing products within 14 days prior to the start of the study
- Females who don't fulfil the criteria for contraception as listed in section 7.5.1 of this protocol
About this study
Official title: Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan After Oral Administration Using 240 ml Non-caloric Water, a Carbohydrate Enriched Drink and Grapefruit Juice in Correlation to the Intestinal Availability of Water as Quantified by MRI-based Volumetry in 9 Healthy Male and Female Subjects
The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine, given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml grapefruit juice prior to ingestion and to visualize the localization and to measure the filling volume of stomach, small intestine as well as ascending, transverse and descending colon by T2-weighted magnetic resonance imaging after oral administration of 240 ml water (non-caloric water), after administration of 240 ml caloric drink and after administration of 240 ml grapefruit juice.
- Being tested
- Paracetamol, Sulfasalazine, Fexofenadine, Valsartan, non-caloric water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Oral administration of 250 mg paracetamol
SulfasalazineDrug
Oral administration of 50 mg sulfasalazine
FexofenadineDrug
Oral administration of 120 mg fexofenadine
ValsartanDrug
Oral administration of 40 mg valsartan
non-caloric waterDevice
Oral administration of 240 ml non-caloric water
caloric drinkDevice
Oral administration of 240 ml caloric drink
grapefruit juiceDevice
Oral administration of 240 ml grapefruit juice
| Study group | Role | What they receive |
|---|---|---|
| non-caloric water | Placebo comparator | 50 mg sulfasalazine given in 240 ml table water after 6 h fasting and 250 mg paracetamol, 120 mg fexofenadine and 40 mg valsartan given in 240 ml non-caloric water 3 h thereafter Receives: Drug: Paracetamol; Drug: Sulfasalazine; Drug: Fexofenadine; Drug: Valsartan; Device: non-caloric water |
| caloric drink | Active comparator | 50 mg sulfasalazine given in 240 ml table water after 6 h fasting and 250 mg paracetamol, 120 mg fexofenadine and 40 mg valsartan given in 240 ml caloric drink 3 h thereafter Receives: Drug: Paracetamol; Drug: Sulfasalazine; Drug: Fexofenadine; Drug: Valsartan; Device: caloric drink |
| grapefruit juice | Active comparator | 50 mg sulfasalazine given in 240 ml table water after 6 h fasting and 250 mg paracetamol, 120 mg fexofenadine and 40 mg valsartan given in 240 ml grapefruit juice 3 h thereafter Receives: Drug: Paracetamol; Drug: Sulfasalazine; Drug: Fexofenadine; Drug: Valsartan; Device: grapefruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the concentration time curve (AUC)
Computed with the measured concentration of Paracetamol, Fexofenadine and Valsartan in blood samples.
Measured: up to 51 h after drug administration
area under the curve of small bowel water volume
Dynamic enhanced magnetic resonance examination gradient-echo T2-weighted HASTE images (TR 1300 ms, TR 321 ms, flip-angle 160°) will be acquired on a 1.5 Tesla MRI. A tube filled with 20 ml water will be fitted on the abdomen of the volunteers in order to have an internal reference for imaging. The obtained MRI files will be investigated with common radiological software (OsiriX, Voxar 3D, Fiji, 3D slicer). From the DICOM files there will obtained: Gastrointestinal volumes and their kinetics for stomach, small bowel, colon segments and gallbladder.
Measured: up to 6.75 h after drug administration
gastric emptying rate
Dynamic enhanced magnetic resonance examination gradient-echo T2-weighted HASTE images (TR 1300 ms, TR 321 ms, flip-angle 160°) will be acquired on a 1.5 Tesla MRI. A tube filled with 20 ml water will be fitted on the abdomen of the volunteers in order to have an internal reference for imaging. The obtained MRI files will be investigated with common radiological software (OsiriX, Voxar 3D, Fiji, 3D slicer). From the DICOM files there will obtained: Gastrointestinal volumes and their kinetics for stomach, small bowel, colon segments and gallbladder. Gastric emptying rate will be estimated as the half life of water volumen in the stomach.
Measured: up to 6.75 h after drug administration
lag-Time of sulfapyridine (orocecal transit times)
Estimated as the first significant concentration (>50 or 100 ng/ml) of sulfapyridine in blood samples after administration of Sulfasalazine.
Measured: up to 51 h after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012763
- Sponsor's protocol ID
- GIT-Physiol_2016
- Status last verified
- Jan 2017
- First submitted
- 5 Jan 2017
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Sulfasalazine, Paracetamol, Fexofenadine and Valsartan After Oral Administration Using 240 ml Non-caloric Water, a Carbohydrate Enriched Drink and Grapefruit Juice in Correlation to the Intestinal Availability of Water as Quantified by MRI-based Volumetry in 9 Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03012763
- Acronym / sponsor ID
- GIT-Physiol_2016
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jan 2017 (actual)
- First posted
- 6 Jan 2017 (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.
The purpose of this study is to determine pharmacokinetics of the probe-drugs sulfasalazine, given in 240 ml non-caloric water and paracetamol, fexofenadine and valsartan after oral administration, given in 240 ml non-caloric water, in 240 ml caloric drink or in 240 ml grapefruit juice prior to ingestion and to visualize the localization and to measure the filling volume of stomach, small intestine as well as ascending, transverse and descending colon by T2-weighted magnetic resonance imaging after oral administration of 240 ml water (non-caloric water), after administration of 240 ml caloric drink and after administration of 240 ml grapefruit juice.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-caloric water | Placebo comparator | Drug: Paracetamol, Drug: Sulfasalazine, Drug: Fexofenadine, Drug: Valsartan, Device: non-caloric water50 mg sulfasalazine given in 240 ml table water after 6 h fasting and 250 mg paracetamol, 120 mg fexofenadine and 40 mg valsartan given in 240 ml non-caloric water 3 h thereafter |
| caloric drink | Active comparator | Drug: Paracetamol, Drug: Sulfasalazine, Drug: Fexofenadine, Drug: Valsartan, Device: caloric drink50 mg sulfasalazine given in 240 ml table water after 6 h fasting and 250 mg paracetamol, 120 mg fexofenadine and 40 mg valsartan given in 240 ml caloric drink 3 h thereafter |
| grapefruit juice | Active comparator | Drug: Paracetamol, Drug: Sulfasalazine, Drug: Fexofenadine, Drug: Valsartan, Device: grapefruit juice50 mg sulfasalazine given in 240 ml table water after 6 h fasting and 250 mg paracetamol, 120 mg fexofenadine and 40 mg valsartan given in 240 ml grapefruit juice 3 h thereafter |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ethnic origin: Caucasian
- body mass index: ≥ 18.5 kg/m² and ≤ 30 kg/m²
- good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state
- written informed consent
Key exclusion criteria (29 listed)
- weight less than 45 kg
- claustrophobia
- tinnitus
- cardiac pacemakers, metallic, plastic or silicone implants, dental retainer or metal-containing tattoos and piercings, Permanent Make-Ups, intrauterine devices
- known allergic reactions/ hypersensitivity to the active ingredients used or to constituents of the study medication (e.g. lactose, lecithin, sulfonamides, salicylates)
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 |
|---|---|---|
| ParacetamolOral administration of 250 mg paracetamol | Drug | caloric drink, grapefruit juice, non-caloric water |
| SulfasalazineOral administration of 50 mg sulfasalazine | Drug | caloric drink, grapefruit juice, non-caloric water |
| FexofenadineOral administration of 120 mg fexofenadine | Drug | caloric drink, grapefruit juice, non-caloric water |
| ValsartanOral administration of 40 mg valsartan | Drug | caloric drink, grapefruit juice, non-caloric water |
| non-caloric waterOral administration of 240 ml non-caloric water | Device | non-caloric water |
| caloric drinkOral administration of 240 ml caloric drink | Device | caloric drink |
| grapefruit juiceOral administration of 240 ml grapefruit juice | Device | grapefruit juice |
Primary outcome
area under the concentration time curve (AUC)
Time frame: up to 51 h after drug administration
Computed with the measured concentration of Paracetamol, Fexofenadine and Valsartan in blood samples.
area under the curve of small bowel water volume
Time frame: up to 6.75 h after drug administration
Dynamic enhanced magnetic resonance examination gradient-echo T2-weighted HASTE images (TR 1300 ms, TR 321 ms, flip-angle 160°) will be acquired on a 1.5 Tesla MRI. A tube filled with 20 ml water will be fitted on the abdomen of the volunteers in order to have an internal reference for imaging. The obtained MRI files will be investigated with common radiological software (OsiriX, Voxar 3D, Fiji, 3D slicer). From the DICOM files there will obtained: Gastrointestinal volumes and their kinetics for stomach, small bowel, colon segments and gallbladder.
gastric emptying rate
Time frame: up to 6.75 h after drug administration
Dynamic enhanced magnetic resonance examination gradient-echo T2-weighted HASTE images (TR 1300 ms, TR 321 ms, flip-angle 160°) will be acquired on a 1.5 Tesla MRI. A tube filled with 20 ml water will be fitted on the abdomen of the volunteers in order to have an internal reference for imaging. The obtained MRI files will be investigated with common radiological software (OsiriX, Voxar 3D, Fiji, 3D slicer). From the DICOM files there will obtained: Gastrointestinal volumes and their kinetics for stomach, small bowel, colon segments and gallbladder. Gastric emptying rate will be estimated as the half life of water volumen in the stomach.
lag-Time of sulfapyridine (orocecal transit times)
Time frame: up to 51 h after drug administration
Estimated as the first significant concentration (>50 or 100 ng/ml) of sulfapyridine in blood samples after administration of Sulfasalazine.
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 6 Jan 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paracetamol, Sulfasalazine and Fexofenadine in people with Pharmacokinetics and Magnetic Resonance Imaging, run by University Medicine Greifswald.
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 4 inclusion and 29 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
area under the concentration time curve (AUC) (time frame: up to 51 h after drug administration). The study lists 4 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 6 Jan 2017.