HealthyPhase 1NCT02211911
Pharmacokinetics of Bisacodyl or Sodium Picosulfate Administered Orally in Healthy Lactating Females
A Phase 1 study testing Bisacodyl and Sodium picosulfate in people with Healthy, run by Boehringer Ingelheim.
Trial summary
To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in breast milk of healthy lactating women after an oral administration of 10 mg once daily over a period of 8 days. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Bisacodyl and Sodium picosulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to May 2008
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women, age ≥18 and ≤50 years
- Stopped with breast feeding their baby
- Provided breast milk samples over a period of 10 days (including day -1)
- Have been breast feeding for at least 14 days
- Complied with the requirements of the protocol (e.g complete a diary)
- Body Mass Index (BMI) ≤ 35 kg/m2
- Medically acceptable method of contraception [i.e., double barrier method (e.g., diaphragm or condom and spermicide), hormonal therapy (subcutaneous, injectable, intra-vaginal, or oral contraceptive) or intrauterine device
- Signed and dated a written informed consent prior to any study procedures study in accordance with Good Clinical practice (GCP) and the local legislation
Who cannot join
- Findings during medical examination (including BP, pulse rate and ECG) deviating from normal and of clinical relevance
- Evidence of clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency, myocardial infarction, other known cardiovascular disease including hypertension
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, that may interfere with the safety of the subject
- Surgery of the gastrointestinal tract (except appendectomy) in the last 2 years
- Metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that would interfere with participation in the study
- History of relevant orthostatic hypotension, fainting spells or blackouts
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- Chronic or relevant acute infections (e.g. HIV, Hepatitis)
- Participated in another study with an investigational product within 1 month prior to enrolment into this study or during the study
- Eating disorder
- Hypersensitivity to bisacodyl, sodium picosulfate or any of the inactive ingredients
- Any concomitant medication except for paracetamol or hormonal therapy.
- Abnormal electrolyte values at the screening visit. The electrolyte values should be within the normal ranges
- Alcohol abuse; subjects who report regular consumption of 40g/day = 5 units/day or more alcoholic drinks per day were excluded
- Smoker (>10 cigarettes or > 3 cigars or > 3 pipes/day)
- Drug abuse
- Any laboratory value outside the reference range that is of clinical relevance
- Mastitis
- Less than 200 ml daily (24 hours) production of breast milk on day -1
- A positive pregnancy test at screening
About this study
Official title: Investigation of the Pharmacokinetics of 10 mg Bisacodyl (Coated Tablets) or 10 mg Sodium Picosulfate (Drops) Administered Orally in Healthy Lactating Females
To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in breast milk of healthy lactating women after an oral administration of 10 mg once daily over a period of 8 days.
- Conditions
- Healthy
- Being tested
- Bisacodyl, Sodium picosulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisacodylDrug
Sodium picosulfateDrug
| Study group | Role | What they receive |
|---|---|---|
| Bisacodyl | Experimental | Not described Receives: Drug: Bisacodyl |
| Sodium picosulfate | Experimental | Not described Receives: Drug: Sodium picosulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 8 days
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Measured: up to 8 days
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)
Measured: up to 8 days
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to 8 days
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
Measured: up to 8 days
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
Measured: up to 8 days
λz (terminal rate constant in plasma)
Measured: up to 8 days
t1/2 (terminal half-life of the analyte in plasma)
Measured: up to 8 days
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: up to 8 days
CL/F (apparent clearance of the analyte in plasma following extravascular administration)
Measured: up to 8 days
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
Measured: up to 8 days
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Measured: up to 8 days
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: up to 8 days
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: up to 8 days
Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2)
Measured: up to 8 days
fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2)
Measured: up to 8 days
AUCτ,milk (area under the concentration-time curve of the analyte in milk over a uniform dosing interval τ after administration of the first dose)
Measured: up to 8 days
milk to plasma ratio (AUCτ,milk / AUCτ)
Measured: up to 8 days
estimated daily infant dosage
(milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)
Measured: up to 8 days
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: up to 8 days
Secondary outcomes (5)
Number of patients with adverse events
Measured: up to 8 days
Number of patients with abnormal laboratory findings
Measured: up to 8 days
Number of patients with abnormal electrocardiogram findings
Measured: up to 8 days
Number of patients with clinically significant changes in vital signs
Measured: up to 8 days
Number of bowel movements
Measured: up to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
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
- None (open label)
- Enrolment
- 16 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
- NCT02211911
- Sponsor's protocol ID
- 122.57
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Pharmacokinetics of 10 mg Bisacodyl (Coated Tablets) or 10 mg Sodium Picosulfate (Drops) Administered Orally in Healthy Lactating Females
- ClinicalTrials.gov ID
- NCT02211911
- Acronym / sponsor ID
- 122.57
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- First posted
- 8 Aug 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.
To investigate if bisacodyl (Dulcolax®) and sodium picosulfate (Laxoberal®) is excreted in breast milk of healthy lactating women after an oral administration of 10 mg once daily over a period of 8 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bisacodyl | Experimental | Drug: Bisacodyl |
| Sodium picosulfate | Experimental | Drug: Sodium picosulfate |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women, age ≥18 and ≤50 years
- Stopped with breast feeding their baby
- Provided breast milk samples over a period of 10 days (including day -1)
- Have been breast feeding for at least 14 days
- Complied with the requirements of the protocol (e.g complete a diary)
Key exclusion criteria (19 listed)
- Findings during medical examination (including BP, pulse rate and ECG) deviating from normal and of clinical relevance
- Evidence of clinically relevant concomitant diseases like renal insufficiency, cardiac insufficiency, myocardial infarction, other known cardiovascular disease including hypertension
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, that may interfere with the safety of the subject
- Surgery of the gastrointestinal tract (except appendectomy) in the last 2 years
- Metabolic disorders, neurological disorders, severe or psychiatric disorders, or any other significant disease or intercurrent illness (e.g. abdominal/gastrointestinal surgery) that would interfere with participation in the study
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 |
|---|---|---|
| Bisacodyl | Drug | Bisacodyl |
| Sodium picosulfate | Drug | Sodium picosulfate |
Primary outcome
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 8 days
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: up to 8 days
AUCτ,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval τ after administration of the first dose)
Time frame: up to 8 days
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 8 days
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable concentration at tz)
Time frame: up to 8 days
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation)
Time frame: up to 8 days
λz (terminal rate constant in plasma)
Time frame: up to 8 days
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 8 days
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: up to 8 days
CL/F (apparent clearance of the analyte in plasma following extravascular administration)
Time frame: up to 8 days
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular administration)
Time frame: up to 8 days
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: up to 8 days
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 8 days
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 8 days
Aet1-t2,milk (amount of analyte in milk from the time point t1 to time point t2)
Time frame: up to 8 days
fet1-t2,milk (fraction of analyte in milk from time point t1 to time point t2)
Time frame: up to 8 days
AUCτ,milk (area under the concentration-time curve of the analyte in milk over a uniform dosing interval τ after administration of the first dose)
Time frame: up to 8 days
milk to plasma ratio (AUCτ,milk / AUCτ)
Time frame: up to 8 days
estimated daily infant dosage
Time frame: up to 8 days
(milk-to-plasma ratio x average maternal plasma concentration x 150 mL/kg/day)
Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to 8 days
5 secondary outcomes
Number of patients with adverse events
Time frame: up to 8 days
Number of patients with abnormal laboratory findings
Time frame: up to 8 days
Number of patients with abnormal electrocardiogram findings
Time frame: up to 8 days
Number of patients with clinically significant changes in vital signs
Time frame: up to 8 days
Number of bowel movements
Time frame: up to 8 days
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 8 Aug 2014.
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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 Bisacodyl and Sodium picosulfate 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 8 inclusion and 19 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 8 Aug 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 (maximum measured concentration of the analyte in plasma) (time frame: up to 8 days). The study lists 20 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 8 Aug 2014.