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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGS649 high dose | Experimental | 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules. |
|
| BGS649 low dose | Experimental | 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules |
|
| Placebo to BGS649 | Placebo Comparator | 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active treatment with a high dose of BGS649 | Drug |
| ||
| Active treatment with a low dose of BGS649 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger | Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Profille of BGS649 as Described by AUC0-672h | AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose. | 8 hours |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Parkin, PhD FRCP | Mereo BioPharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anaheim | California | 92801 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BGS649 High Dose | 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules |
| FG001 | BGS649 Low Dose | 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules |
| FG002 | Placebo | 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BGS649 High Dose | 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules |
| BG001 | BGS649 Low Dose | 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger | Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger. | Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger | Posted | Count of Participants | Participants | 8 months |
|
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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 | BGS649 High Dose | 1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
The study was prematurely terminated because the safety endpoint was reached after a total of 6 patients were randomized into one of the 3 treatment arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Parkin | Mereo BioPharma | +44 333 0237300 | enquiries@mereobiopharma.com |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D007246 | Infertility |
| D010146 | Pain |
| D014623 | Vaginal Diseases |
| D014591 | Uterine Diseases |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Drug |
|
| Placebo treatment to blind study | Drug |
|
| Pharmacokinetic Profile of BGS649 as Described by Cmax |
The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose. |
| 8 hours |
| Pharmacokinetic Profile of BGS649 as Described by Tmax | Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose. | 8 hours |
| BG002 | Placebo | 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo
|
|
| Secondary | Pharmacokinetic Profille of BGS649 as Described by AUC0-672h | AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose. | Full analysis set | Posted | Mean | Full Range | ng*hr/mL | 8 hours |
|
|
|
| Secondary | Pharmacokinetic Profile of BGS649 as Described by Cmax | The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose. | Pharmacokinetic patient population. Study met the pre-defined safety stopping criteria and so was not fully enrolled. The PK results of for one of the patients could not be reported - missing data for cycle 2 and meeting the stopping criteria before cycle 4. | Posted | Mean | Standard Deviation | ng/mL | 8 hours |
|
|
|
| Secondary | Pharmacokinetic Profile of BGS649 as Described by Tmax | Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose. | Pharmacokinetic patient population. Study met the pre-defined safety stopping criteria and so was not fully enrolled. The PK results of for one of the patients could not be reported - missing data for cycle 2 and meeting the stopping criteria before cycle 4. | Posted | Mean | Full Range | hours | 8 hours |
|
|
|
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | BGS649 Low Dose | 1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules | 0 | 2 | 2 | 2 |
| EG002 | Placebo | 1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules | 0 | 2 | 2 | 2 |
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
All PIs must seek written permission from the sponsor prior to publication of any trial results.
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |