PharmacokineticsPhase 1NCT03011463
Pharmacokinetic Interaction Between Trospium With an Inhibitor of OCT1 and of P-gp in Subjects Genotyped for OCT1
A Phase 1 study testing intravenous infusion of 2 mg trospium chloride, oral administration of 30 mg trospium chloride and oral administration of 300 mg ranitidine in people with Pharmacokinetics and Inhibition Enzyme, run by Dr. R. Pfleger Chemische Fabrik GmbH.
Trial summary
The purpose of the study is: to determine absolute bioavailability, input rates, distribution volume, renal and intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357 to determine absolute… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Inhibition Enzyme, Drug Interaction Potentiation
- What is being tested?
- intravenous infusion of 2 mg trospium chloride, oral administration of 30 mg trospium chloride and oral administration of 300 mg ranitidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Mar 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
- genotypes of OCT1: wild-type and homozygous variant alleles of SLC22A1 rs72552763 or rs12208357.
- 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 (blood pressure between 110/70 and 140/90 for males and between 100/60 and 140/90 for females, heart rate over 50 bpm up to 90 bpm, laboratory values within the reference ranges as given actually by the laboratory and stored in the TMF)
- written informed consent
Who cannot join
- hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication (e.g. hepatic or renal dysfunction, obstruction of the urine flow with urinary retention by subvesical obstruction like benign prostatic hyperplasia, infections or tumors of the urinary tract)
- organic causes for polydipsia and pollakiuria
- existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics (e.g. tachycardia, tachyarrhythmia, bradycardia, heart failure, coronary heart disease, disturbance of the stimulus conduction)
- pneumonia
- pharyngitis
- acute phorphyria
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- hyperthyroidism
- galactose-intolerance, lactase deficiency or glucose-galactose malabsorption
- electrolyte disturbance
- gastrointestinal diseases and/or pathological findings (e.g. hiatus hernia with gastroesophageal reflux, stenosis, ulcera, severe chronic inflammatory bowel disease like ulcerative colitis or Crohn's disease, toxic megacolon), which might interfere with pharmacokinetics and pharmacodynamics of the study medication)
- autonomic neuropathy
- myasthenia gravis
- narrow-angle glaucoma
- drug or alcohol dependence
- positive drug or alcohol screening
- smokers of 10 or more cigarettes per day
- positive results in HIV, HBV and HCV screenings
- subjects who are on a diet which could affect the pharmacokinetics of the drugs (e. g. vegans, vegetarians)
- heavy tea or coffee drinkers (more than 1L per day)
- lactation, pregnancy test positive or not performed or women of child-bearing age without safe contraception as stated in the Note for Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceutical (CPMP/ICH/286/95 modifications: implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner and barrier-methods only in combination with one of the aforementioned)
- subjects suspected or known not to follow instructions of the clinical investigators
- 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 start of the study
- less than 14 days after last acute disease
- less than 3 months after last blood donation
- any medication within 4 weeks prior to the intended first administration of the study medication which might influence functions of the gastrointestinal tract (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists, proton pump inhibitors, anticholinergics)
- any other medication within two weeks prior to the first administration of the study medication, but at least 10-time the half-live of the respective drug (except oral contraceptives)
- intake of grapefruit or orange containing food or beverages within 14 days prior to administration of the study medication
- intake of poppy seed containing food or beverages within 14 days prior to administration of the study medication
- known allergic reactions to the active ingredients used, other H2-receptor antagonists, macrolide antibiotics or to constituents of the study medication
About this study
Official title: Pharmacokinetic Interaction Between Trospium Chloride After Intravenous (2 mg) and Oral Administration (30 mg) With Ranitidine (300 mg p.o.) as an Inhibitor of OCT1 and With Clarithromycin (500 mg p.o.) as an Inhibitor of P-glycoprotein in 24 Healthy Subjects Genotyped for OCT1
The purpose of the study is:
- to determine absolute bioavailability, input rates, distribution volume, renal and intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357
- to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1 rs72552763 and rs12208357 after co-medication of 300 mg of the OCT1- inhibitor ranitidine
- to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1 rs72552763 and rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor clarithromycin
- to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor clarithromycin.
- Being tested
- intravenous infusion of 2 mg trospium chloride, oral administration of 30 mg trospium chloride, oral administration of 300 mg ranitidine, oral administration of 500 mg clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous infusion of 2 mg trospium chlorideDrug
intravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and 240 ml tap water p.o
oral administration of 30 mg trospium chlorideDrug
oral administration of 30 mg trospium chloride with 240 ml tap water
oral administration of 300 mg ranitidineDrug
oral administration of 300 mg ranitidine with 240 ml tap water
oral administration of 500 mg clarithromycinDrug
oral administration of 500 mg clarithromycin with 240 ml tap water
| Study group | Role | What they receive |
|---|---|---|
| trospium intravenous | Active comparator | Intravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and 240 ml tap water p.o. Receives: Drug: intravenous infusion of 2 mg trospium chloride |
| trospium oral | Active comparator | Oral administration of 30 mg trospium chloride with 240 ml tap water Receives: Drug: oral administration of 30 mg trospium chloride |
| trospium intravenous with ranitidine | Active comparator | Intravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and oral administration of 300 mg ranitidine with 240 ml tap water Receives: Drug: intravenous infusion of 2 mg trospium chloride; Drug: oral administration of 300 mg ranitidine |
| trospium intravenous with clarithromycin | Active comparator | Intravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and oral administration of 500 mg clarithromycin with 240 ml tap water Receives: Drug: intravenous infusion of 2 mg trospium chloride; Drug: oral administration of 500 mg clarithromycin |
| trospium oral with ranitidine | Active comparator | Oral administration of 30 mg trospium chloride together with 300 mg ranitidine with 240 ml tap water Receives: Drug: oral administration of 30 mg trospium chloride; Drug: oral administration of 300 mg ranitidine |
| trospium oral with clarithromycin | Active comparator | Oral administration of 30 mg trospium chloride together with 500 mg clarithromycin with 240 ml tap water Receives: Drug: oral administration of 30 mg trospium chloride; Drug: oral administration of 500 mg clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute bioavailability
ratio oral over intravenous area under the concentration time curve normalized by given dose
Measured: up to 36 h after drug administration
Secondary outcomes (4)
input rates
Measured: up to 36 h after drug administration
volume of distribution
Measured: up to 36 h after drug administration
renal excretion
Measured: up to 36 h after drug administration
intestinal excretion
Measured: up to 36 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 posted5 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. R. Pfleger Chemische Fabrik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Tarek Roustom, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011463
- Sponsor's protocol ID
- P334
- Status last verified
- Apr 2017
- First submitted
- 2 Jan 2017
- Last updated
- 10 Apr 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 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Interaction Between Trospium Chloride After Intravenous (2 mg) and Oral Administration (30 mg) With Ranitidine (300 mg p.o.) as an Inhibitor of OCT1 and With Clarithromycin (500 mg p.o.) as an Inhibitor of P-glycoprotein in 24 Healthy Subjects Genotyped for OCT1
- ClinicalTrials.gov ID
- NCT03011463
- Acronym / sponsor ID
- P334
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dr. R. Pfleger Chemische Fabrik GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 5 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 the study is:
- to determine absolute bioavailability, input rates, distribution volume, renal and intestinal excretion of trospium in subjects with wild-type of SLC22A1 rs72552763 and rs12208357 and in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357
- to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1 rs72552763 and rs12208357 after co-medication of 300 mg of the OCT1- inhibitor ranitidine
- to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with wild-type alleles of SLC22A1 rs72552763 and rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor clarithromycin
- to determine absolute bioavailability, input rates, distribution volume and renal and intestinal excretion of trospium in subjects with homozygous variant alleles of SLC22A1 rs72552763 or rs12208357 after co-medication of 500 mg of the P-glycoprotein- inhibitor clarithromycin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| trospium intravenous | Active comparator | Drug: intravenous infusion of 2 mg trospium chlorideIntravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and 240 ml tap water p.o. |
| trospium oral | Active comparator | Drug: oral administration of 30 mg trospium chlorideOral administration of 30 mg trospium chloride with 240 ml tap water |
| trospium intravenous with ranitidine | Active comparator | Drug: intravenous infusion of 2 mg trospium chloride, Drug: oral administration of 300 mg ranitidineIntravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and oral administration of 300 mg ranitidine with 240 ml tap water |
| trospium intravenous with clarithromycin | Active comparator | Drug: intravenous infusion of 2 mg trospium chloride, Drug: oral administration of 500 mg clarithromycinIntravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and oral administration of 500 mg clarithromycin with 240 ml tap water |
| trospium oral with ranitidine | Active comparator | Drug: oral administration of 30 mg trospium chloride, Drug: oral administration of 300 mg ranitidineOral administration of 30 mg trospium chloride together with 300 mg ranitidine with 240 ml tap water |
| trospium oral with clarithromycin | Active comparator | Drug: oral administration of 30 mg trospium chloride, Drug: oral administration of 500 mg clarithromycinOral administration of 30 mg trospium chloride together with 500 mg clarithromycin with 240 ml tap water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ethnic origin: Caucasian
- genotypes of OCT1: wild-type and homozygous variant alleles of SLC22A1 rs72552763 or rs12208357.
- 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 (blood pressure between 110/70 and 140/90 for males and between 100/60 and 140/90 for females, heart rate over 50 bpm up to 90 bpm, laboratory values within the reference ranges as given actually by the laboratory and stored in the TMF)
- written informed consent
Key exclusion criteria (31 listed)
- hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics and pharmacodynamics of the study medication (e.g. hepatic or renal dysfunction, obstruction of the urine flow with urinary retention by subvesical obstruction like benign prostatic hyperplasia, infections or tumors of the urinary tract)
- organic causes for polydipsia and pollakiuria
- existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics (e.g. tachycardia, tachyarrhythmia, bradycardia, heart failure, coronary heart disease, disturbance of the stimulus conduction)
- pneumonia
- pharyngitis
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 |
|---|---|---|
| intravenous infusion of 2 mg trospium chlorideintravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and 240 ml tap water p.o | Drug | trospium intravenous, trospium intravenous with clarithromycin, trospium intravenous with ranitidine |
| oral administration of 30 mg trospium chlorideoral administration of 30 mg trospium chloride with 240 ml tap water | Drug | trospium oral, trospium oral with clarithromycin, trospium oral with ranitidine |
| oral administration of 300 mg ranitidineoral administration of 300 mg ranitidine with 240 ml tap water | Drug | trospium intravenous with ranitidine, trospium oral with ranitidine |
| oral administration of 500 mg clarithromycinoral administration of 500 mg clarithromycin with 240 ml tap water | Drug | trospium intravenous with clarithromycin, trospium oral with clarithromycin |
Primary outcome
absolute bioavailability
Time frame: up to 36 h after drug administration
ratio oral over intravenous area under the concentration time curve normalized by given dose
4 secondary outcomes
input rates
Time frame: up to 36 h after drug administration
volume of distribution
Time frame: up to 36 h after drug administration
renal excretion
Time frame: up to 36 h after drug administration
intestinal excretion
Time frame: up to 36 h after drug administration
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 10 Apr 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 intravenous infusion of 2 mg trospium chloride, oral administration of 30 mg trospium chloride and oral administration of 300 mg ranitidine in people with Pharmacokinetics and Inhibition Enzyme, run by Dr. R. Pfleger Chemische Fabrik GmbH.
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 5 inclusion and 31 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 10 Apr 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. 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?
absolute bioavailability (time frame: up to 36 h after drug administration). 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 10 Apr 2017.