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

NCT04074174 | Completed Phase 1

• 2 other identifiers: NN9838-4517U1111-1228-4219
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

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

  h\*pg/mL

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

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

  h\*pg/mL

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

Secondary Outcomes (6)

• Cmax,EE, SS, maximum concentration of ethinylestradiol at steady state

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

• Cmax,LN,SS, maximum concentration of levonorgestrel at steady state

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

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

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

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

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

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

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

Study Arms (1)

NNC0174-0833 treatment-free period; NNC0174-0833 treatment

EXPERIMENTAL

During the NNC0174-0833 treatment-free period participants will receive OC tablets and acetaminophen. During the NNC0174-0833 treatment period participants will receive OC tablets and acetaminophen in addition to NNC0174-0833.

Drug: NNC0174-0833; Drug: Oral contraceptive (OC) tablets; Drug: Acetaminophen

Interventions

NNC0174-0833 DRUG

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

NNC0174-0833 treatment-free period; NNC0174-0833 treatment

Oral contraceptive (OC) tablets DRUG

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

NNC0174-0833 treatment-free period; NNC0174-0833 treatment

Acetaminophen DRUG

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

NNC0174-0833 treatment-free period; NNC0174-0833 treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Montreal, Quebec, H3P 3P1, Canada

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Contraceptives, Oral; Tablets; Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Dosage Forms; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 29, 2019
• Study Start: September 12, 2019
• Primary Completion: March 6, 2020
• Study Completion: March 6, 2020
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)