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

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
NNC0174-0833
Oral contraceptive (OC) tablets
Acetaminophen
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

AUC0-24h,EE,SS area under the ethinylestradiol concentration-time curve during a dosing interval (0-24 hours) at steady state
h*pg/mL
AUC0-24h,LN,SS area under the levonorgestrel concentration-time curve during a dosing interval (0-24 hours) at steady state
h*pg/mL

Secondary Outcome Measures

Cmax,EE, SS, maximum concentration of ethinylestradiol at steady state
pg/mL
Cmax,LN,SS, maximum concentration of levonorgestrel at steady state
pg/mL
tmax,EE,SS time to maximum concentration of ethinylestradiol at steady state
h
tmax,LN,SS, time to maximum concentration of levonorgestrel at steady state
h
AUC0-60min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-60 minutes following a standardised meal
h*microg/mL
AUC0-360min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-360 minutes following a standardised meal
h*microg/mL

Full Information

First Posted
August 28, 2019
Last Updated
January 6, 2022
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04074174
Brief Title
Research Study to Investigate the Effect of NNC0174-0833 on a Birth Control Pill in Women Who Are Not Able to Become Pregnant
Official Title
Investigation of the Effect of NNC0174-0833 on Pharmacokinetics of an Oral Combination Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NNC0174-0833 treatment-free period; NNC0174-0833 treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NNC0174-0833
Intervention Description
NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Oral contraceptive (OC) tablets
Intervention Description
1 tablet daily on days 1-8 and days 79-86
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Single dose of acetaminophen as part of a standardised meal on day 1 and day 79
Primary Outcome Measure Information:
Title
AUC0-24h,EE,SS area under the ethinylestradiol concentration-time curve during a dosing interval (0-24 hours) at steady state
Description
h*pg/mL
Time Frame
Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Title
AUC0-24h,LN,SS area under the levonorgestrel concentration-time curve during a dosing interval (0-24 hours) at steady state
Description
h*pg/mL
Time Frame
Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Secondary Outcome Measure Information:
Title
Cmax,EE, SS, maximum concentration of ethinylestradiol at steady state
Description
pg/mL
Time Frame
Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Title
Cmax,LN,SS, maximum concentration of levonorgestrel at steady state
Description
pg/mL
Time Frame
Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Title
tmax,EE,SS time to maximum concentration of ethinylestradiol at steady state
Description
h
Time Frame
Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Title
tmax,LN,SS, time to maximum concentration of levonorgestrel at steady state
Description
h
Time Frame
Day 8 (predose to 24 hours post-dose) and Day 79 (predose to 24 hours post-dose)
Title
AUC0-60min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-60 minutes following a standardised meal
Description
h*microg/mL
Time Frame
Day 1 (predose to 60 minutes post-dose) and Day 79 (predose to 60 minutes post-dose)
Title
AUC0-360min,para, area under the acetaminophen (paracetamol) concentration-time curve for 0-360 minutes following a standardised meal
Description
h*microg/mL
Time Frame
Day 1 (predose to 360 minutes post-dose) and Day 79 (predose to 360 minutes post-dose)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure (1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3P 3P1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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