Healthy VolunteersPhase 1NCT01036893
M0001 Effects on Oral Contraceptive Plasma Levels
A Phase 1 study testing prucalopride in people with Healthy Volunteers, run by Movetis at 1 site in Germany.
Trial summary
This is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial. The objectives of this phase I trial are to investigate in healthy female subjects: the effect of prucalopride on the absorption of ethinylestradiol and norethisterone acetate, the active constituents of several oral… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to May 2010
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who meet all of the following criteria are eligible for this trial:
- Healthy females, aged between 18 and 45 years extremes included, who have regular menstrual cycle of 28 ± 3 days for the last 6 months.
- Adequate use of non-hormonal birth control (double-barrier method (e.g. condom and spermicide, cervical cap and spermicide) or sterilization or vasectomy of the partner or certified abstinence).
- Subjects are not smoking for at least 6 months prior to selection.
- A body mass index (BMI) between 18 and 27 kg/m2, extremes included.
- The subject is in good health based on a pre-trial physical and gynaecological examination, medical history, anamnesis, electrocardiogram (ECG) and the results of biochemistry, coagulation or haematology tests or a urinalysis carried out within 4 weeks before the start of the trial. If the results of the biochemistry, coagulation or haematology tests or the urinalysis are not within the laboratory's reference ranges the subject will be included only on condition that the investigator judges that the deviations are not clinically significant.
- Subjects voluntarily signed written Informed Consent Form (ICF) in accordance with the regional laws or regulations, prior to the first trial related activity, indicating an understanding of the purpose of this trial.
- Subjects are willing to adhere to the treatment regimen and trial procedures described in this protocol.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the trial:
- History, evidence or suspicion of alcohol or drug abuse (screening and Day -1).
- History or evidence of cardiac arrhythmias, bronchospastic or cardiovascular disease (e.g. ischemic heart disease or cerebrovascular accident), hepatic or gastrointestinal, renal or endocrine (diabetes mellitus, thyrotoxicosis), or neurological (Parkinsonism) or psychiatric, gynaecological or dermatological disease, drug allergy.
- Clinical significant abnormal ECG-intervals of morphology of the ECG, QT >500 ms or QTcB>470 ms.
- Use of concomitant medication or oral contraceptives within 6 weeks prior to screening, or any hormonal depot-device within 6 months prior to screening . All medication, with the exception of paracetamol should be stopped.
- Participation in an investigational drug trial in 30 days prior to the first visit.
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- Donation of blood in the 60 days preceding the first visit.
- Pregnancy (as confirmed by a HCG test during screening and at Day 1 of each treatment session before dosing) or breast feeding.
- Subjects with positive results for HIV, hepatitis B or C at screening.
- Known allergy to the trial drugs ingredients/excipients.
- Subject has contraindications for the use of oral contraceptives (known or suspected active venous thrombo-embolic disorder, known or suspected hormone dependent malignancies, undiagnosed vaginal bleeding, coagulation disorders, menstrual cycle depending migraine, lipid metabolism disorders, hepatic disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prucalopride on the Plasma Levels of Oral Contraceptives (Ethinylestradiol and Norethisterone) in Healthy Subjects
This is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial.
The objectives of this phase I trial are to investigate in healthy female subjects:
- the effect of prucalopride on the absorption of ethinylestradiol and norethisterone acetate, the active constituents of several oral contraceptives, after the first dose of prucalopride.
- the effect of multiple oral dosing of 2 mg prucalopride, for 6 days o.d. (steady state), on the pharmacokinetics of ethinylestradiol and norethisterone acetate.
This trial will be conducted in healthy females of child bearing potential, i.e. females aged between 18 and 45 years (pre-menopausal).
- Conditions
- Healthy Volunteers
- Being tested
- prucalopride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prucaloprideDrug
prucalopride 2 mg oral dosing o.d. for 6 days
| Study group | Role | What they receive |
|---|---|---|
| oral contraceptives without prucalopride | No intervention | Not described |
| oral contraceptives with prucalopride | Active comparator | prucalopride Receives: Drug: prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma levels oral contraceptives
Measured: first days
Plasma levels oral contraceptives after steady state
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Movetis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FOCUS GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036893
- Sponsor's protocol ID
- M0001-C101
- Status last verified
- Jun 2010
- First submitted
- 18 Dec 2009
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Van de Velde V, Vandeplassche L, Hoppenbrouwers M, Boterman M, Ausma J. Effect of prucalopride on the pharmacokinetics of oral contraceptives in healthy women. Drugs R D. 2013 Mar;13(1):43-51. doi: 10.1007/s40268-013-0008-6.
PubMed 23539257
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prucalopride on the Plasma Levels of Oral Contraceptives (Ethinylestradiol and Norethisterone) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01036893
- Acronym / sponsor ID
- M0001-C101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- MovetisIndustry (pharma, biotech, devices)
- Collaborators
- FOCUS GmbH
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 Dec 2009 (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 is a randomized, open-label, two-way cross-over drug-drug interaction Phase I trial.
The objectives of this phase I trial are to investigate in healthy female subjects:
- the effect of prucalopride on the absorption of ethinylestradiol and norethisterone acetate, the active constituents of several oral contraceptives, after the first dose of prucalopride.
- the effect of multiple oral dosing of 2 mg prucalopride, for 6 days o.d. (steady state), on the pharmacokinetics of ethinylestradiol and norethisterone acetate.
This trial will be conducted in healthy females of child bearing potential, i.e. females aged between 18 and 45 years (pre-menopausal).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral contraceptives without prucalopride | No intervention | – |
| oral contraceptives with prucalopride | Active comparator | Drug: prucaloprideprucalopride |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy females, aged between 18 and 45 years extremes included, who have regular menstrual cycle of 28 ± 3 days for the last 6 months.
- Adequate use of non-hormonal birth control (double-barrier method (e.g. condom and spermicide, cervical cap and spermicide) or sterilization or vasectomy of the partner or certified abstinence).
- Subjects are not smoking for at least 6 months prior to selection.
- A body mass index (BMI) between 18 and 27 kg/m2, extremes included.
- The subject is in good health based on a pre-trial physical and gynaecological examination, medical history, anamnesis, electrocardiogram (ECG) and the results of biochemistry, coagulation or haematology tests or a urinalysis carried out within 4 weeks before the start of the trial. If the results of the biochemistry, coagulation or haematology tests or the urinalysis are not within the laboratory's reference ranges the subject will be included only on condition that the investigator judges that the deviations are not clinically significant.
Key exclusion criteria (11 listed)
- History, evidence or suspicion of alcohol or drug abuse (screening and Day -1).
- History or evidence of cardiac arrhythmias, bronchospastic or cardiovascular disease (e.g. ischemic heart disease or cerebrovascular accident), hepatic or gastrointestinal, renal or endocrine (diabetes mellitus, thyrotoxicosis), or neurological (Parkinsonism) or psychiatric, gynaecological or dermatological disease, drug allergy.
- Clinical significant abnormal ECG-intervals of morphology of the ECG, QT >500 ms or QTcB>470 ms.
- Use of concomitant medication or oral contraceptives within 6 weeks prior to screening, or any hormonal depot-device within 6 months prior to screening . All medication, with the exception of paracetamol should be stopped.
- Participation in an investigational drug trial in 30 days prior to the first visit.
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 |
|---|---|---|
| prucaloprideprucalopride 2 mg oral dosing o.d. for 6 days | Drug | oral contraceptives with prucalopride |
Primary outcome
plasma levels oral contraceptives
Time frame: first days
Plasma levels oral contraceptives after steady state
Time frame: 5 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 17 May 2011.
- Derived from this study: PubMed 23539257Van de Velde V, Vandeplassche L, Hoppenbrouwers M, Boterman M, Ausma J. Effect of prucalopride on the pharmacokinetics of oral contraceptives in healthy women. Drugs R D. 2013 Mar;13(1):43-51. doi: 10.1007/s40268-013-0008-6.
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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.
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 prucalopride in people with Healthy Volunteers, run by Movetis at 1 site in Germany.
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 11 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 17 May 2011. 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 Germany. 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?
plasma levels oral contraceptives (time frame: first days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01036893, which also lists 1 linked publication.
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 17 May 2011.