A Research Study Looking at How the Compound NNC0194-0499 Works With Birth Control Pills in Women Not Able to Bear Children.

NCT06188026 | Completed Phase 1

• 3 other identifiers: NN9500-4619U1111-1279-38432023-503595-24-00
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the influence of NNC0194-0499 on the blood levels of the two components of a birth control pill, Microgynon®. Participants will get the birth control pill in form of tablets in two periods of 8 days each. Participants will get NNC0194-0499 as injection under the skin of their thigh. The injections will be given once weekly for 5 weeks. The study will last for about 11 to 15 weeks, depending on the length of the screening period. Participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) Only healthy women who are not able to bear children can take part in this study.

Conditions

Healthy Volunteers (Non-alcoholic Steatohepatitis)

Outcome Measures

Primary Outcomes (2)

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

  h-pg/mL

  Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)

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

  h-pg/mL

  Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)

Secondary Outcomes (5)

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

  Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)

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

  Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)

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

  Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)

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

  Day 8 (pre-dose to 24 hours post-dose) and Day 38 (pre-dose to 24 hours post-dose)

• Number of treatment emergent adverse events (TEAEs)

  Day 1 to Day 8, and Day 31 to Day 38.

Study Arms (1)

Sequence 1

EXPERIMENTAL

All participants will be exposed to both interventions in a defined sequence. OC 8 days, NNC0194-0499 4 weeks, OC/NNC0194-0499 combined 1 week.

Drug: NNC0194-0499; Drug: ethinylestradiol/levonorgestrel

Interventions

NNC0194-0499 DRUG

Once a week for 5 weeks as an injection in dose of 30 mg. The injection will be given under the skin

Sequence 1

ethinylestradiol/levonorgestrel DRUG

Oral contraceptive is taken as tablet daily composed of 30 μg ethinylestradiol and 150 μg levonorgestrel.

Sequence 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female of non-childbearing potential.
• Age 18-65 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 18.5 and 29.9 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.

You may not qualify if:

• Any disorder 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 Prescription Drug Information.
• Sitting blood pressure at screening outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic.
• Pulse outside the range of 50-89 beats/minute at screening
• 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: use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or topical medication not reaching systemic circulation.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Ethinyl Estradiol; Levonorgestrel

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Norgestrel; Norpregnenes

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

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

Model Details: single-centre, one-sequence cross-over, open-label study

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 3, 2024
• Study Start: December 18, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)