- To assess the effect of QBW251 on the pharmacokinetics of a monophasic combined oral contraceptive containing 30 µg ethinyl estradiol (EE) and 150 µg levonorgestrel (LVG).- To assess the effect of QBW251 on the pharmacodynamics of a monophasic…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders congenital
- Menstrual cycle and uterine bleeding disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Confirmatory
PK
PD
Secondary outcome
Not applicable
Background summary
To study the pharmacokinetic and pharmacodynamic effects of QBW251 on the oral
contraceptive pill.
Study objective
- To assess the effect of QBW251 on the pharmacokinetics of a monophasic
combined oral contraceptive containing 30 µg ethinyl estradiol (EE) and 150 µg
levonorgestrel (LVG).
- To assess the effect of QBW251 on the pharmacodynamics of a monophasic
combined oral contraceptive containing 30 µg ethinyl
estradiol (EE) and 150 µg levonorgestrel (LVG) as determined by Follicle
Stimulating Hormone (FSH), Luteinizing Hormone (LH), estradiol, Progesterone
and Sex Hormone Binding Globulin (SHBG) concentrations and ovarian follicle
size as represented by the Hoogland Score.
- To assess the safety, tolerability of QBW251 when administered orally.
- To assess the pharmacokinetics of QBW251 when administered orally.
Study design
This is a confirmatory, phase I, open-label, single sequence, two-treatment
period study in premenopausal healthy female volunteers.
Intervention
The study will start with a screening visit. During the screening visit
standard medical assessments including safety laboratory tests (blood draw,
urine collection), an alcohol breath test, urine drug screen, a physical
examination, ECG and a vital signs measurement will be performed. In addition
standard aPTT test and Factor V Leiden Mutation test be performed.
After the subject passes all above mentioned tests, the subject will be
enrolled in the synchronization phase if the subject is not taking a monophasic
OC for at least 3 cycles. The synchronization phase consists at least 3 OC
cycles.
During study the subject will enter the clinic. In P1, the subjects will
receive 1 medication (an OC) daily from day 1 to day 21. In P2, the subjects
will receive 1 medication (an OC) daily from day 1 to day 21 and twice daily
the study medication (QBW251). The subject will be asked on a regular basis for
possible side effects, blood will be drawn for safety, PK, and PD measurements
and the vital signs/ECG will be checked during the 2 confinement periods and
ambulant visits. During the pill-free periods, the subject will not return to
the clinic.
Finally a follow-up examination will be performed. During this visit the
subjects will be asked for possible side effects, blood will be drawn for
safety and PD, the vital signs/ECG will be checked and a physical examination
will be conducted.
Study burden and risks
The risk is small. The patients will be closely monitored. The patients will be
regularly questioned for any side effects and safety tests are scheduled (ECG /
Vital Signs). The patients will be asked to report, as soon as possible, any
changes in physical and/or mental well being.
The blood collection procedure is not dangerous, but may cause discomfort or
bruising. Occasionally, fainting or an infection at the blood sampling site may
occur.
Shaving may be required for proper placemant of ECG patches. This may cause
irritation or bleeding of the skin. ECG patches may cause redness, itching,
rash, or blisters on the skin and/or hair loss due to removal of ECG patches.
Wimblehurst Road 1
Horsham RH12 5AB
GB
Wimblehurst Road 1
Horsham RH12 5AB
GB
Listed location countries
Age
Inclusion criteria
Healthy premenopausal female subjects age 18 to 50 years of age. Stable regimen of monophasic OC containing EE (30 µg)/LVG (150 µg) for at least three cycles prior to dosing in treatment period.;Any Subject not taking any OC or taking another brand of;monophasic OC (which does not contain 30 µg EE and 150 µg LVG);should be willing to take a monophasic OC containing 30 µg EE and;150 µg LVG for at least three cycles during synchronization until day -7.;Negative pregnancy test results at screening and both baseline;visits.
Exclusion criteria
Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations.;Women of child-bearing potential, defined as all women;physiologically capable of becoming pregnant, unless they are using contraception methods.;Women who are either heterozygous or homozygous for the Factor V Leiden mutation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-004895-36-NL |
| CCMO | NL49077.056.14 |