NCT04074174

Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant

Investigation of the Effect of NNC0174-0833 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study looks at how the study medicine affects the level in the blood of a birth control pill. The study also looks at how the study medicine affects the duration of emptying of the stomach. Participants will get 1 injection of study medicine once a week for 12 weeks by a study nurse at the clinic. The study medicine is injected with a thin needle in a skin fold in the stomach. In addition, participants will get 1 birth control pill per day for 8 days before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Participants will also get a dose of acetaminophen before the first dose of the study medicine and again after 10 weeks of dosing with the study medicine. Acetaminophen is a mild painkiller but used here to assess the emptying of the stomach. The study will last for about 9 months, but participants will only be in the study for about 6 months. Participants will have 17 clinic visits with the study staff and some will be overnight visits. There will also be 3 phone calls with the study staff. At all visits, participants will have blood drawn along with other clinical assessments. Participants will be asked about their health, diseases and habits including mental health questionnaires. Participants must not be able to become pregnant if they want to participate in the study.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	NNC0174-0833	NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks
DRUG	Oral contraceptive (OC) tablets	1 tablet daily on days 1-8 and days 79-86
DRUG	Acetaminophen	Single dose of acetaminophen as part of a standardised meal on day 1 and day 79

Timeline

• Start date: 2019-09-12
• Primary completion: 2020-03-06
• Completion: 2020-03-06
• First posted: 2019-08-29
• Last updated: 2022-01-10

Locations

1 site across 1 country: Canada