CompletedPhase 1

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

Investigation of the Effect of NNC0194-0499 on Pharmacokinetics of a Combined Oral Contraceptive (Ethinylestradiol and Levonorgestrel) in Females of Non-childbearing Potential. .

Lead sponsor

Novo Nordisk A/S

Asset

NNC0194-0499

Subcutaneous · FGF21 analog

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 18.5-29.9•Female•Healthy volunteers

Primary endpoints

•(AUC0-24h,EE,SS), AUC of ethinylestradiol during a dosing interval at steady•(AUC0-24h,LN,SS), AUC of levonorgestrel during a dosing interval at steady state

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06188026

Org study IDNN9500-4619

Secondary ID2023-503595-24-00EU CT Number

Secondary IDU1111-1279-3843World Health Organization (WHO)

Timeline

Milestones

Study start2023-12-18actual

Study first posted2024-01-03actual

Primary completion2024-12-30actual

Study completion2024-12-30actual

Last update posted2025-02-18actual

Assets

Investigational agents

NNC0194-0499

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•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.

Exclusion criteria

•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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

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