DRUG
NNC0487-0111 A
NNC0487-0111 A will be administered subcutaneously.
A Research Study Looking at How the Compound NNC0487-0111 Works With Birth Control Pills and Affects Emptying of the Stomach in Women Not Able to Become Pregnant
Status
Completed
Phase
Phase 1
Enrollment
43
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
NNC0487-0111 C
NNC0487-0111 C will be taken orally.
DRUG
Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC)
Levonorgestrel 150 μg + Ethinylestradiol 30 μg (Oral contraceptive OC) will be taken orally.
DRUG
Acetaminophen - 500 mg/15 ml
Acetaminophen - 500 mg/15 ml will be taken orally.
Timeline
From registration to results.
First posted
Jun 14, 2024
Study start
Jun 14, 2024
Primary completion
Mar 16, 2025
Study completion
Apr 4, 2025
Results posted
Not reported
Registry updated
May 8, 2025
Outcomes
What the study measures.
Primary outcomes
The area under the ethinylestradiol plasma concentration time curve at steady state
Time frame · Day 8 and Day 193
Measured as hours picograms per milliliter (h\*pg/mL).
The area under the levonorgestrel plasma concentration time curve at steady state
Time frame · Day 8 and Day 193
Measured as hours picograms per milliliter (h\*pg/mL).
Secondary outcomes
Maximum ethinylestradiol plasma concentration at steady state
Time frame · Day 8 and Day 193
Measured as picograms per milliliter (pg/mL).
Maximum levonorgestrel plasma concentration at steady state
Time frame · Day 8 and Day 193
Measured as picograms per milliliter (pg/mL).
The area under the ethinylestradiol plasma concentration time curve at steady state
Time frame · Day 8 and Day 135
Measured as hours picograms per milliliter (h\*pg/mL).
The area under the levonorgestrel plasma concentration time curve at steady state
Time frame · Day 8 and Day 135
Measured as hours picograms per milliliter (h\*pg/mL).
Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state
Time frame · Day 8 and Day 135
Measured as picograms per milliliter (pg/mL).
Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state
Time frame · Day 8 and Day 135
Measured as picograms per milliliter (pg/mL).
AUC1 area under the acetaminophen concentration-time curve following a standardised meal
Time frame · Day 1 and Day 186
Measured as hours micro grams per milliliter (h\*μg/mL).
AUC2 area under the acetaminophen concentration-time curve following a standardised meal
Time frame · Day 1 and Day 186
Measured as hours micro grams per milliliter (h\*μg/mL).
Cmax,para, maximum acetaminophen plasma concentration following a standardised meal
Time frame · Day 1 and Day 186
Measured as micrograms per milliliter (μg/mL).
AUC3 area under the acetaminophen concentration-time curve following a standardised meal
Time frame · Day 1 and Day 128
Measured as hours micro grams per milliliter (h\*μg/mL).
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: * Females of non-childbearing potential. * Age 18 - 65 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening. * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Any contraindications for the use of the oral contraception used in the study according to the Microgynon Product Information. * Use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic CYP pathways, such as hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. Exceptions are routine vitamins, occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation. * History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator.
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Altasciences Clinical Company, Inc
Montreal, Quebec, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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