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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000298-62 | EudraCT Number | EudraCT |
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Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 207127 + faldaprevir + Microgynon | Experimental | Period A: Microgynon®; Period B: Microgynon® + FDV + BI 207127 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| faldaprevir | Drug | oral doses for 10 days (period B) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCtau,ss of Ethinylestradiol | Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss). | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
| Cmax,ss of Ethinylestradiol | Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
| C24,ss of Ethinylestradiol | Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration. | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
| AUCtau,ss of Levonogestrel | Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t. | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
| Cmax,ss of Levonogestrel | Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t. |
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Inclusion criteria:
Exclusion criteria:
Use of hormone-containing intrauterine device, depot injection or contraceptive implants
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.31.2 Boehringer Ingelheim Investigational Site | Mannheim | Germany |
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This trial was planned to include 18 healthy premenopausal female subjects. Because this trial was prematurely discontinued during the run-in period, only 16 subjects were entered.
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| ID | Title | Description |
|---|---|---|
| FG000 | Deleobuvir + Faldaprevir + Microgynon | This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run in Treatment: Microgynon® |
| |||||||||||||
| Reference Treatment: Microgynon® |
| |||||||||||||
| Microgynon® Plus Deleobuvir+Faldaprevir |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Deleobuvir + Faldaprevir + Microgynon | This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | AUCtau,ss of Ethinylestradiol | Area under the concentration-time curve of ethinylestradiol in plasma at steady state over a uniform dosing interval t (AUCtau,ss). | Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined. | Posted | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
|
until end of run-in period up to 49 days
study was terminated after run-in period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deleobuvir + Faldaprevir + Microgynon | In the run-in period starting between Day -56 and Day -28, all subjects were to take 1 Microgynon® tablet (combined oral contraceptive ethinylestradiol / levonorgestrel) once daily for 21 to 49 days (depending on the menstrual cycle) until Day -8. In the last 7 days of the run-in period (Day -7 to Day -1), no treatment was given in order to induce withdrawal bleeding. The next day was to be Day 1 of the study. Subjects who were using oral contraceptives before the study started the run-in period after the usual tablet-free interval of 7 days. Subjects who were using hormonal contraceptive vaginal rings before the study started the run-in-period after the usual hormone-free interval of 7 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 16.1 | Systematic Assessment |
This trial was prematurely discontinued during the run-in period. During the run-in period, subjects were to receive Microgynon® once daily for 21 to 49 days. The investigational products Deleobuvir + faldaprevir were not administered.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | +1 800 243 0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| C552340 | faldaprevir |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| C000592437 | deleobuvir |
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| Microgynon® |
| Drug |
oral doses for 23 days (period A+B) |
|
| BI 207127 | Drug | oral doses for 10 days (period B) |
|
| Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
| C24,ss of Levonogestrel | Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration. | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Cmax,ss of Ethinylestradiol | Maximum measured concentration of ethinylestradiol in plasma at steady state over a uniform dosing interval t | Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined. | Posted | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
|
|
| Primary | C24,ss of Ethinylestradiol | Measured concentration of ethinylestradiol in plasma at steady state 24 hours after drug administration. | Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined. | Posted | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
|
|
| Primary | AUCtau,ss of Levonogestrel | Area under the concentration-time curve of levonogestrel in plasma at steady state over a uniform dosing interval t. | Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined. | Posted | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
|
|
| Primary | Cmax,ss of Levonogestrel | Maximum measured concentration of levonogestrel in plasma at steady state over a uniform dosing interval t. | Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined. | Posted | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
|
|
| Primary | C24,ss of Levonogestrel | Measured concentration of levonogestrel in plasma at steady state 24 hours after drug administration. | Since this trial was prematurely discontinued during the run-in period, no blood samples for pharmacokinetics were collected and therefore no pharmacokinetic endpoints could be determined. | Posted | Visit (V)3: 2 hours(h) pre dose, 240, 264, 288, 288.5, 289, 289.5, 290, 291, 292, 294, 296, 298, 300 h post dose; V4: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 216.5, 217, 217.5, 218, 219, 220, 222, 224, 226, 228, 240 h post dose for oral contraceptives |
|
|
| 0 |
| 16 |
| 4 |
| 16 |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 16.1 | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | MEDDRA 16.1 | Systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MEDDRA 16.1 | Systematic Assessment |
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| Uterine pain | Reproductive system and breast disorders | MEDDRA 16.1 | Systematic Assessment |
|
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.