DiarrheaPhase 1NCT01476683
Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products
A Phase 1 study testing Racecadotril in people with Diarrhea, run by McNeil AB at 1 site in Canada.
Trial summary
This study is designed to compare the pharmacokinetics of four products used for treatment of acute diarrhea. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Racecadotril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Dec 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects (equal numbers of males and females)
- Volunteers aged of at least 18 years but not older than 55 years
- Subjects will have a Body Mass Index (BMI) within protocol-specified parameters.
- Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
- Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Seated pulse rate and blood pressure within protocol-specified parameters.
- Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson subsidiaries; and the families of each)
- Females who are pregnant or are lactating
- Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
- History of significant hypersensitivity to racecadotril or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
- Use of certain drugs/medications within protocol-specified timeframes
- Medical history or condition that may, per protocol or in the opinion of the investigator, adversely affect the safety of the study subject or compromise study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Fasting, Crossover, Single-Dose Pharmacokinetic Study of Four Formulations of Racecadotril
This study is designed to compare the pharmacokinetics of four products used for treatment of acute diarrhea.
Read the detailed description
The study will be a single dose, randomized, four -way, four-sequence crossover study in 24 healthy subjects, with equal numbers of males and females (minimum of 10 of either gender). Subjects who drop out will not be replaced. The four doses of medication given in the study (a single dose in each of the four study periods) will be separated by a washout period of at least 7 calendar days. In each study period, 17 blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of thiorphan (the active metabolite) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data.
- Conditions
- Diarrhea
- Being tested
- Racecadotril
- Keywords
- Antidiarrheals
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RacecadotrilDrug
Also called Not yet marketed
Film-coated tablet
RacecadotrilDrug
Also called Not yet marketed
Racecadotril Powder Blend
RacecadotrilDrug
Also called Tiorfast®
Marketed Capsule
RacecadotrilDrug
Also called Tiorfanor®
Marketed Film-coated Tablet
| Study group | Role | What they receive |
|---|---|---|
| FCT | Experimental | A single 2 x100 mg dose of an experimental Racecadotril Film-coated tablet (FCT) administered orally with 240 ml of water, with a 7- day washout between visits. Receives: Drug: Racecadotril |
| RPB | Experimental | A single 2 x100 mg dose of an experimental Racecadotril Powder Blend administered orally with 240 ml of water, with a 7- day washout between visits. Receives: Drug: Racecadotril |
| TFT | Active comparator | A single 2 x 100 mg dose of a marketed Tiorfast® capsule administered orally with 240 ml of water, with a 7-day washout between visits. Receives: Drug: Racecadotril |
| TFR | Active comparator | A single 175 mg dose of a marketed Tiorfanor® 175 mg FCT administered orally with 240 ml of water, with a 7-day washout between visits. Receives: Drug: Racecadotril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
AUC(0-t)
AUC(0-t) is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour*nanograms (ng) per milliliter (mL).
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
AUC(0-∞)
AUC (0-∞) is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.
Measured: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
Secondary outcomes (4)
Time of Maximum Concentration
The time at which maximum concentration is reached (Tmax)
Measured: During 12 hours post-dose
Terminal Elimination Rate Constant
The Terminal Elimination Rate Constant (Lamda z) is the time required to eliminate half the administered dose
Measured: During 12 hours post-dose
Terminal Phase Plasma Half-Life
Terminal phase plasma half-life (t ½) is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, rather than the time required to eliminate half the administered dose.
Measured: During 12 hours post-dose
Lag Time
The time delay between drug administration and the quantification of absorption
Measured: During 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabeth Kruse, PhD, Study director, McNeil AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476683
- Sponsor's protocol ID
- RACDIR1002
- Status last verified
- Jul 2012
- First submitted
- 17 Nov 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Fasting, Crossover, Single-Dose Pharmacokinetic Study of Four Formulations of Racecadotril
- ClinicalTrials.gov ID
- NCT01476683
- Acronym / sponsor ID
- RACDIR1002
- Conditions
- Diarrhea
- Keywords
- Antidiarrheals
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- McNeil ABIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Nov 2011 (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.
This study is designed to compare the pharmacokinetics of four products used for treatment of acute diarrhea.
Detailed description
The study will be a single dose, randomized, four -way, four-sequence crossover study in 24 healthy subjects, with equal numbers of males and females (minimum of 10 of either gender). Subjects who drop out will not be replaced. The four doses of medication given in the study (a single dose in each of the four study periods) will be separated by a washout period of at least 7 calendar days. In each study period, 17 blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of thiorphan (the active metabolite) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FCT | Experimental | Drug: RacecadotrilA single 2 x100 mg dose of an experimental Racecadotril Film-coated tablet (FCT) administered orally with 240 ml of water, with a 7- day washout between visits. |
| RPB | Experimental | Drug: RacecadotrilA single 2 x100 mg dose of an experimental Racecadotril Powder Blend administered orally with 240 ml of water, with a 7- day washout between visits. |
| TFT | Active comparator | Drug: RacecadotrilA single 2 x 100 mg dose of a marketed Tiorfast® capsule administered orally with 240 ml of water, with a 7-day washout between visits. |
| TFR | Active comparator | Drug: RacecadotrilA single 175 mg dose of a marketed Tiorfanor® 175 mg FCT administered orally with 240 ml of water, with a 7-day washout between visits. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female subjects (equal numbers of males and females)
- Volunteers aged of at least 18 years but not older than 55 years
- Subjects will have a Body Mass Index (BMI) within protocol-specified parameters.
- Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
- Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
Key exclusion criteria (7 listed)
- Seated pulse rate and blood pressure within protocol-specified parameters.
- Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson subsidiaries; and the families of each)
- Females who are pregnant or are lactating
- Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
- History of significant hypersensitivity to racecadotril or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
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 |
|---|---|---|
| RacecadotrilAlso: Not yet marketedFilm-coated tablet | Drug | FCT |
| RacecadotrilAlso: Not yet marketedRacecadotril Powder Blend | Drug | RPB |
| RacecadotrilAlso: Tiorfast®Marketed Capsule | Drug | TFT |
| RacecadotrilAlso: Tiorfanor®Marketed Film-coated Tablet | Drug | TFR |
Primary outcome
Maximum Observed Plasma Concentration
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered, measured in nanograms/milliliter (ng/mL)
AUC(0-t)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
AUC(0-t) is the area under the plasma concentration verses time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour*nanograms (ng) per milliliter (mL).
AUC(0-∞)
Time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post drug administration
AUC (0-∞) is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.
4 secondary outcomes
Time of Maximum Concentration
Time frame: During 12 hours post-dose
Terminal Elimination Rate Constant
Time frame: During 12 hours post-dose
Terminal Phase Plasma Half-Life
Time frame: During 12 hours post-dose
Lag Time
Time frame: During 12 hours post-dose
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 Jul 2012.
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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.
Elisabeth Kruse, PhD study director
McNeil AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Racecadotril in people with Diarrhea, run by McNeil AB at 1 site in Canada.
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 7 inclusion and 7 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 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Maximum Observed Plasma Concentration (time frame: Pre-dose and 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 12 hours post 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 Jul 2012.