HealthyPhase 1NCT02261077
Pharmacokinetics, Safety and Tolerability of Rising Doses of Buscopan® in Healthy Male Volunteers
A Phase 1 study testing Hyoscine butylbromide in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single rising dose and after multiple rising doses Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hyoscine butylbromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Jul 2007
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
- Age ≥21 and age ≤50 years
- BMI ≥18.5 and BMI <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 26Show fewer
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to randomization
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug within two months prior to randomization
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 40 g/day for males)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities within one week prior to administration or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Hypersensitivity to hyoscine butylbromide and/or related drugs of these classes
- History of megacolon
- History of prostatic hyperplasia
- History of mechanical stenosis of the gastrointestinal (e.g. after surgery of the gastrointestinal tract)
- History of narrow-angle glaucoma
- History of tachycardic arrhythmias
- History of myasthenia gravis
- Bladder-neck obstruction
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Single Rising Oral Doses (20 mg, 60 mg, 100 mg, 200 mg and 400 mg) and Multiple Rising Oral Doses (3 x 20 mg, 3 x 60 mg and 3 x 100 mg Per Day) of Buscopan® in Healthy Male Volunteers
Study to investigate pharmacokinetics, safety and tolerability of Buscopan® after single rising dose and after multiple rising doses
- Conditions
- Healthy
- Being tested
- Hyoscine butylbromide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine butylbromideDrug
Also called Buscopan®
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Buscopan, single rising doses | Experimental | Not described Receives: Drug: Hyoscine butylbromide |
| Buscopan, multiple rising doses | Experimental | Not described Receives: Drug: Hyoscine butylbromide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measured concentration of analyte in plasma (Cmax)
Measured: up to 104 hours after last drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 104 hours after last drug administration
Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Measured: up to 80 hours after last drug administration
Secondary outcomes (22)
Time from dosing to maximum measured concentration (tmax)
Measured: up to 104 hours after last drug administration
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose (AUCτ,1)
Measured: up to 32 hours after drug administration
Terminal rate constant in plasma (λz)
Measured: up to 104 hours after last drug administration
Terminal half-life of the analyte in plasma (t1/2)
Measured: up to 104 hours after last drug administration
Mean residence time of the analyte in the body (MRTpo)
Measured: up to 104 hours after last drug administration
Total/apparent clearance in plasma after extravascular administration (CL/F)
Measured: up to 104 hours after last drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Measured: up to 104 hours after last drug administration
Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Measured: up to 80 hours after last drug administration
Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
Measured: up to 80 hours after last drug administration
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Measured: up to 80 hours after last drug administration
Average concentration of the analyte in plasma at steady-state (Cavg)
Measured: up to 104 hours after last drug administration
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Measured: up to 104 hours after last drug administration
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Measured: predose on days 1-4
Linearity index (LI)
Measured: up to 104 hours after last drug administration
Accumulation ratio (RA) based on Cmax (RA,Cmax,N)
Measured: up to 104 hours after last drug administration
RA,AUC,N based on AUC0-τ
Measured: up to 104 hours after last drug administration
Number of subjects with clinically relevant findings in vital sign parameters (blood pressure (BP), pulse rate (PR))
Measured: up to 14 days after last drug administration
Number of subjects with clinically relevant findings in 12-lead electrocardiogram
Measured: up to 14 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters
Measured: up to 14 days after last drug administration
Number of subjects with abnormal findings in physical examination
Measured: up to 14 days after last drug administration
Occurrence of adverse events
Measured: up to 47 days
Tolerability assessed by investigator on a 4-point scale
Measured: within 14 days after last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startMay 2007
- Primary completionJul 2007
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 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
- NCT02261077
- Sponsor's protocol ID
- 202.833
- Status last verified
- Oct 2014
- First submitted
- 9 Oct 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Assess Pharmacokinetics, Safety and Tolerability of Single Rising Oral Doses (20 mg, 60 mg, 100 mg, 200 mg and 400 mg) and Multiple Rising Oral Doses (3 x 20 mg, 3 x 60 mg and 3 x 100 mg Per Day) of Buscopan® in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02261077
- Acronym / sponsor ID
- 202.833
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jul 2007 (actual)
- First posted
- 10 Oct 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 pharmacokinetics, safety and tolerability of Buscopan® after single rising dose and after multiple rising doses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Buscopan, single rising doses | Experimental | Drug: Hyoscine butylbromide |
| Buscopan, multiple rising doses | Experimental | Drug: Hyoscine butylbromide |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
- Age ≥21 and age ≤50 years
- BMI ≥18.5 and BMI <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Key exclusion criteria (26 listed)
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Hyoscine butylbromideAlso: Buscopan® | Drug | Buscopan, multiple rising doses, Buscopan, single rising doses |
| Placebo | Drug | Placebo |
Primary outcome
Maximum measured concentration of analyte in plasma (Cmax)
Time frame: up to 104 hours after last drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 104 hours after last drug administration
Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Time frame: up to 80 hours after last drug administration
22 secondary outcomes
Time from dosing to maximum measured concentration (tmax)
Time frame: up to 104 hours after last drug administration
Area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose (AUCτ,1)
Time frame: up to 32 hours after drug administration
Terminal rate constant in plasma (λz)
Time frame: up to 104 hours after last drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 104 hours after last drug administration
Mean residence time of the analyte in the body (MRTpo)
Time frame: up to 104 hours after last drug administration
Total/apparent clearance in plasma after extravascular administration (CL/F)
Time frame: up to 104 hours after last drug administration
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time frame: up to 104 hours after last drug administration
Amount of analyte eliminated in urine from the time point t1 to time point t2 (Aet1-t2)
Time frame: up to 80 hours after last drug administration
Fraction of analyte eliminated in urine from time point t1 to time point t2 (fet1-t2)
Time frame: up to 80 hours after last drug administration
Renal clearance of the analyte from the time point t1 until the time point t2 (CLR,t1-t2)
Time frame: up to 80 hours after last drug administration
Average concentration of the analyte in plasma at steady-state (Cavg)
Time frame: up to 104 hours after last drug administration
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)
Time frame: up to 104 hours after last drug administration
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss)
Time frame: predose on days 1-4
Linearity index (LI)
Time frame: up to 104 hours after last drug administration
Accumulation ratio (RA) based on Cmax (RA,Cmax,N)
Time frame: up to 104 hours after last drug administration
RA,AUC,N based on AUC0-τ
Time frame: up to 104 hours after last drug administration
Number of subjects with clinically relevant findings in vital sign parameters (blood pressure (BP), pulse rate (PR))
Time frame: up to 14 days after last drug administration
Number of subjects with clinically relevant findings in 12-lead electrocardiogram
Time frame: up to 14 days after last drug administration
Number of subjects with abnormal changes in laboratory parameters
Time frame: up to 14 days after last drug administration
Number of subjects with abnormal findings in physical examination
Time frame: up to 14 days after last drug administration
Occurrence of adverse events
Time frame: up to 47 days
Tolerability assessed by investigator on a 4-point scale
Time frame: within 14 days after last 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 Oct 2014.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
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
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 Hyoscine butylbromide 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 4 inclusion and 26 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 Oct 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. 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?
Maximum measured concentration of analyte in plasma (Cmax) (time frame: up to 104 hours after last drug administration). 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 10 Oct 2014.