Clinical trial NCT06461039: 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
Official title: Investigation of the Effect of NNC0487-0111 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) and Gastric Emptying in Females of Non-childbearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-06-14
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The area under the ethinylestradiol plasma concentration time curve at steady state
timeFrame: Day 8 and Day 193
measure: The area under the levonorgestrel plasma concentration time curve at steady state
timeFrame: Day 8 and Day 193
Secondary outcomes:
measure: Maximum ethinylestradiol plasma concentration at steady state
timeFrame: Day 8 and Day 193
measure: Maximum levonorgestrel plasma concentration at steady state
timeFrame: Day 8 and Day 193
measure: The area under the ethinylestradiol plasma concentration time curve at steady state
timeFrame: Day 8 and Day 135
measure: The area under the levonorgestrel plasma concentration time curve at steady state
timeFrame: Day 8 and Day 135
measure: Cmax,EE,SS, maximum ethinylestradiol plasma concentration at steady state
timeFrame: Day 8 and Day 135
measure: Cmax,LN,SS, maximum levonorgestrel plasma concentration at steady state
timeFrame: Day 8 and Day 135
measure: AUC1 area under the acetaminophen concentration-time curve following a standardised meal
timeFrame: Day 1 and Day 186
measure: AUC2 area under the acetaminophen concentration-time curve following a standardised meal
timeFrame: Day 1 and Day 186
measure: Cmax,para, maximum acetaminophen plasma concentration following a standardised meal
timeFrame: Day 1 and Day 186
measure: AUC3 area under the acetaminophen concentration-time curve following a standardised meal
timeFrame: Day 1 and Day 128
measure: AUC4 area under the acetaminophen concentration-time curve following a standardised meal
timeFrame: Day 1 and Day 128
measure: Cmax,para, maximum acetaminophen plasma concentration following a standardised meal
timeFrame: Day 1 and Day 128
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Altasciences Clinical Company, Inc
state: Quebec
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: