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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1300-3685 | Other Identifier | World Health Organization (WHO) |
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This study medicine NNC0487-0111 to improve the treatment options for people living with overweight and obesity or with type 2 diabetes. The purpose of the study is to investigate if NNC0487-0111 affects how effective birth control pills are. Participants will take 1-tablet once daily. The study medicine will taken orally for 18 weeks and then study medicine will be injected with a thin needle in a skin fold in the abdomen for 9 weeks.The study will last for about 35 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 | Experimental | Participants will receive oral dosing of NNC0487-0111 and gradually will escalate from dose 1 to dose 2. The oral NNC0487-0111 treatment will be followed by s.c. NNC0487-0111 treatment with dose escalating from dose 3 to dose 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 A | Drug | NNC0487-0111 A will be administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the ethinylestradiol plasma concentration time curve at steady state | Measured as hours picograms per milliliter (h*pg/mL). | Day 8 and Day 193 |
| The area under the levonorgestrel plasma concentration time curve at steady state | Measured as hours picograms per milliliter (h*pg/mL). | Day 8 and Day 193 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum ethinylestradiol plasma concentration at steady state | Measured as picograms per milliliter (pg/mL). | Day 8 and Day 193 |
| Maximum levonorgestrel plasma concentration at steady state | Measured as picograms per milliliter (pg/mL). |
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Inclusion Criteria:
Exclusion Criteria:
Exceptions are routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Company, Inc | Montreal | Quebec | H3P 3P1 | Canada |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| NNC0487-0111 C |
| Drug |
NNC0487-0111 C will be taken orally. |
|
| Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) | Drug | Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally. |
|
| Acetaminophen - 500 mg/15 ml | Drug | Acetaminophen - 500 mg/15 ml will be taken orally. |
|
| Day 8 and Day 193 |
| The area under the ethinylestradiol plasma concentration time curve at steady state | Measured as hours picograms per milliliter (h*pg/mL). | Day 8 and Day 135 |
| The area under the levonorgestrel plasma concentration time curve at steady state | Measured as hours picograms per milliliter (h*pg/mL). | Day 8 and Day 135 |
| Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state | Measured as picograms per milliliter (pg/mL). | Day 8 and Day 135 |
| Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state | Measured as picograms per milliliter (pg/mL). | Day 8 and Day 135 |
| AUC1 area under the acetaminophen concentration-time curve following a standardised meal | Measured as hours micro grams per milliliter (h*μg/mL). | Day 1 and Day 186 |
| AUC2 area under the acetaminophen concentration-time curve following a standardised meal | Measured as hours micro grams per milliliter (h*μg/mL). | Day 1 and Day 186 |
| Cmax,para, maximum acetaminophen plasma concentration following a standardised meal | Measured as micrograms per milliliter (μg/mL). | Day 1 and Day 186 |
| AUC3 area under the acetaminophen concentration-time curve following a standardised meal | Measured as hours micro grams per milliliter (h*μg/mL). | Day 1 and Day 128 |
| AUC4 area under the acetaminophen concentration-time curve following a standardised meal | Measured as hours micro grams per milliliter (h*μg/mL). | Day 1 and Day 128 |
| Cmax,para, maximum acetaminophen plasma concentration following a standardised meal | Measured as micrograms per milliliter (μg/mL). | Day 1 and Day 128 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016912 | Levonorgestrel |
| D004997 | Ethinyl Estradiol |
| D003270 | Contraceptive Agents |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009651 | Norpregnatrienes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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