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Completed

NCT Number: NCT04074174

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Montreal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female of non-childbearing potential, aged 18-65 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 25.0 and 39.9 kg/m^2 (both inclusive). Overweight should be due to excess adipose tissue, as judged by the investigator.

Exclusion criteria

  • Known or suspected hypersensitivity to trial products (including acetaminophen) or related products.
  • Previous participation in this trial. Participation is defined as signed informed consent.
  • Previous participation in trial(s) with NNC0174-0833 unless documented that the subject was assigned to placebo treatment. Participation is defined as randomised.
  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Treatment and study plan

NNC0174-0833

Drug

NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks

Oral contraceptive (OC) tablets

Drug

1 tablet daily on days 1-8 and days 79-86

Acetaminophen

Drug

Single dose of acetaminophen as part of a standardised meal on day 1 and day 79

Primary outcomes

  1. AUC0-24h,EE,SS area under the ethinylestradiol concentration-time curve during a dosing interval (0-24 hours) at steady state

    Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

    h*pg/mL

  2. AUC0-24h,LN,SS area under the levonorgestrel concentration-time curve during a dosing interval (0-24 hours) at steady state

    Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

    h*pg/mL

Secondary outcomes

  1. Cmax,EE, SS, maximum concentration of ethinylestradiol at steady state

    Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

    pg/mL

  2. Cmax,LN,SS, maximum concentration of levonorgestrel at steady state

    Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

    pg/mL

  3. tmax,EE,SS time to maximum concentration of ethinylestradiol at steady state

    Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

    h

  4. tmax,LN,SS, time to maximum concentration of levonorgestrel at steady state

    Time frame: Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)

    h

  5. AUC0-60min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-60 minutes following a standardised meal

    Time frame: Day 1 (predose to 60 minutes post-dose) and Day 79 (predose to 60 minutes post-dose)

    h*microg/mL

  6. AUC0-360min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-360 minutes following a standardised meal

    Time frame: Day 1 (predose to 360 minutes post-dose) and Day 79 (predose to 360 minutes post-dose)

    h*microg/mL

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 29, 2019
Registry last updated
Jan 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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