A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men

June 10, 2024 updated by: Novo Nordisk A/S

Investigation of Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Chinese Males

This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250062
        • Jinan Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive).
  • Body weight greater than or equal to 60 kg.
  • Considered eligible 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:

  • Known or suspected hypersensitivity to study intervention or related products.
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NNC0194-0499 12 mg
Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1.
Drug: NNC0194-0499
Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.
Drug: NNC0194-0499
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Experimental: NNC0194-0499 30 mg
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Drug: NNC0194-0499
Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.
Drug: NNC0194-0499
Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
Experimental: NNC0194-0499 96 mg
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
Drug: NC0194-0499
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in nanomoles*hours per liter (nmol h/L).
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in nmol/L.
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in hours.
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in hours.
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in liters per hour (L/h).
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in liters (L).
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in triglycerides
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in Percent change.
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in high-density lipoprotein (HDL) cholesterol
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in Percent change.
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Relative change in low-density lipoprotein (LDL) cholesterol
Time Frame: From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
Measured in Percent change.
From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)
AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose
Time Frame: From Day 1 (pre-dose) until Day 7 (168 hours)
Measured in nmol h/L.
From Day 1 (pre-dose) until Day 7 (168 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9500-4796
  • U1111-1267-4230 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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