HealthyPhase 1NCT02172417
Tiotropium in Combination With Concomitant Cimetidine or Ranitidine in Healthy Male and Female Subjects
A Phase 1 study testing Cimetidine + Tiotropium, Ranitidine + Tiotropium and Tiotropium in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate the effect of an inhibition of the renal cationic drug transporter on single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical Chronic Obstructive Pulmonary Disease (COPD) population Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cimetidine + Tiotropium, Ranitidine + Tiotropium and Tiotropium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Nov 2000
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males or females
- Age range from 50 to 65 years
- Within 20% of their normal weight (Broca index)
Who cannot join
- Any finding of the medical examination (including blood pressure, puls rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 25Show fewer
- Intake of a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study or during the study (exclusion: ovarian hormone substitution)
- Use of any drugs which might influence the results of the trial within four weeks prior to administration or during the trial, among these all non-selective β-blockers, cromolyn sodium, nedocromil sodium, oral β-adrenergics or long-acting β-adrenergics such as salmeterol and formoterol, and anticholinergic drugs including ATROVENT® (ipratropium) by oral inhalation or ATROVENT® Nasal Spray
- Participation in another study with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Inability to refrain from smoking on study days
- Alcohol abuse (> 40 g/day)
- Drug abuse
- Blood donation (≥ 100 ml) within four weeks prior to administration or during the trial
- Excessive physical activities within 5 days prior to administration or during the trial
- Any laboratory value outside the reference range of clinical relevance
- Subjects with known hypersensitivity to anticholinergic drugs
- Subjects with known symptomatic prostatic hypertrophy or disturbed micturition
- Subjects with known narrow-angle glaucoma
- In addition for female subjects (if appropriate):
- Pregnancy
- Positive pregnancy test
- No adequate contraception e.g. oral contraceptives, sterilization, intra uterine pessary (IUP)
- Inability to maintain this adequate contraception during the whole study period
- Lactation period
About this study
Official title: The Effect of Concomitant Cimetidine p.o. 400 mg t.i.d. and p.o. Ranitidine 300 mg Once Daily on Single Dose Pharmacokinetics of Tiotropium (14.4 µg) Given Intravenously Over 15 Minutes in Healthy Male and Female Subjects of 50-65 Years (Randomized, Open Label, Two Independent Two-fold Crossover)
Study to investigate the effect of an inhibition of the renal cationic drug transporter on single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical Chronic Obstructive Pulmonary Disease (COPD) population
- Conditions
- Healthy
- Being tested
- Cimetidine + Tiotropium, Ranitidine + Tiotropium, Tiotropium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cimetidine + TiotropiumDrug
Ranitidine + TiotropiumDrug
TiotropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Cimetidine + Tiotropium followed by Tiotropium | Experimental | Not described Receives: Drug: Cimetidine + Tiotropium; Drug: Tiotropium |
| Ranitidine + Tiotropium followed by Tiotropium | Experimental | Not described Receives: Drug: Ranitidine + Tiotropium; Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of plasma levels of tiotropium after dosing
Measured: up to 8 hours after i.v. treatment
Area under the curve (AUC) 0-4h of the plasma levels of tiotropium after dosing
Measured: 0 - 4 hours after i.v. treatment
Urinary excretion 0-4h after dosing (Ae0-4h)
Measured: 0 - 4 hours after i.v. treatment
Renal clearance of tiotropium (CLR)
Measured: pre-dose, 0-4 h, 4-8 h, 8-12 h, 12-24 , 24-28 h, 38-72 h and 72-96 h after i.v. treatment
Secondary outcomes (7)
AUC 0-8h of plasma levels of tiotropium after dosing
Measured: 0-8 hours after treatment
Urinary excretion 0-96h after dosing (Ae0-96h)
Measured: 0-96 hours after treatment
Occurrence of Adverse Events
Measured: up to 4 - 8 days after last i.v. treatment
Changes from baseline in Laboratory Tests
Measured: Baseline, 4 - 8 days after last i.v. treatment
Changes in 12-lead electrocardiogram (ECG)
Measured: up to 24 h after i.v. treatment
Changes in Blood Pressure and Pulse Rate
Measured: up to 4 - 8 days after last i.v. treatment
Changes from baseline in physical examination
Measured: Baseline, 4 - 8 days after last i.v. treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJul 2000
- Primary completionNov 2000
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 Boehringer IngelheimThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172417
- Sponsor's protocol ID
- 205.222
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Concomitant Cimetidine p.o. 400 mg t.i.d. and p.o. Ranitidine 300 mg Once Daily on Single Dose Pharmacokinetics of Tiotropium (14.4 µg) Given Intravenously Over 15 Minutes in Healthy Male and Female Subjects of 50-65 Years (Randomized, Open Label, Two Independent Two-fold Crossover)
- ClinicalTrials.gov ID
- NCT02172417
- Acronym / sponsor ID
- 205.222
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2000
- Primary completion
- Nov 2000 (actual)
- First posted
- 24 Jun 2014 (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.
Study to investigate the effect of an inhibition of the renal cationic drug transporter on single dose pharmacokinetics of intravenous tiotropium in subjects in an age close to typical Chronic Obstructive Pulmonary Disease (COPD) population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cimetidine + Tiotropium followed by Tiotropium | Experimental | Drug: Cimetidine + Tiotropium, Drug: Tiotropium |
| Ranitidine + Tiotropium followed by Tiotropium | Experimental | Drug: Ranitidine + Tiotropium, Drug: Tiotropium |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males or females
- Age range from 50 to 65 years
- Within 20% of their normal weight (Broca index)
Key exclusion criteria (25 listed)
- Any finding of the medical examination (including blood pressure, puls rate and ECG) deviating from normal and of clinical relevance
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
- History of orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
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 |
|---|---|---|
| Cimetidine + Tiotropium | Drug | Cimetidine + Tiotropium followed by Tiotropium |
| Ranitidine + Tiotropium | Drug | Ranitidine + Tiotropium followed by Tiotropium |
| Tiotropium | Drug | Cimetidine + Tiotropium followed by Tiotropium, Ranitidine + Tiotropium followed by Tiotropium |
Primary outcome
Cmax of plasma levels of tiotropium after dosing
Time frame: up to 8 hours after i.v. treatment
Area under the curve (AUC) 0-4h of the plasma levels of tiotropium after dosing
Time frame: 0 - 4 hours after i.v. treatment
Urinary excretion 0-4h after dosing (Ae0-4h)
Time frame: 0 - 4 hours after i.v. treatment
Renal clearance of tiotropium (CLR)
Time frame: pre-dose, 0-4 h, 4-8 h, 8-12 h, 12-24 , 24-28 h, 38-72 h and 72-96 h after i.v. treatment
7 secondary outcomes
AUC 0-8h of plasma levels of tiotropium after dosing
Time frame: 0-8 hours after treatment
Urinary excretion 0-96h after dosing (Ae0-96h)
Time frame: 0-96 hours after treatment
Occurrence of Adverse Events
Time frame: up to 4 - 8 days after last i.v. treatment
Changes from baseline in Laboratory Tests
Time frame: Baseline, 4 - 8 days after last i.v. treatment
Changes in 12-lead electrocardiogram (ECG)
Time frame: up to 24 h after i.v. treatment
Changes in Blood Pressure and Pulse Rate
Time frame: up to 4 - 8 days after last i.v. treatment
Changes from baseline in physical examination
Time frame: Baseline, 4 - 8 days after last i.v. treatment
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 24 Jun 2014.
- Related InfoLink provided by the sponsor.
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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 Cimetidine + Tiotropium, Ranitidine + Tiotropium and Tiotropium in people with Healthy, run by Boehringer Ingelheim.
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 3 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 24 Jun 2014. 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?
Cmax of plasma levels of tiotropium after dosing (time frame: up to 8 hours after i.v. treatment). 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 24 Jun 2014.