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A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men

Primary Purpose

Non-alcoholic Steatohepatitis

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

NNC0194-0499

Placebo (NNC0194-0499 )

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male, aged 20-55 years (both inclusive) at the time of signing informed consent
For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent
Body mass index (BMI) between 23.0 and 34.9 kg/m^2 (both inclusive)
Body weight greater than or equal to 60 kg

Exclusion Criteria:

Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NN0194-0499

Placebo

Arm Description

Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo, Asian participants will only receive NNC0194-0499. There will be 3 cohorts with escalating dose levels. There should be at least 4 days between dose administration of the last participant in a dose level cohort and dose administration of the first participant in the following dose level cohort.

Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo.

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)

Count of events

Secondary Outcome Measures

AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration

h·nmol/L

AUC0-tz, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time of the last quantifiable sample after a single s.c. administration

h·nmol/L

AUC0-168h, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration

h·nmol/L

Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration

nmol/L

tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration

Hours

t½, SD: Terminal half-life of NNC0194-0499

Hours

CL/FSD: Apparent total serum clearance of NNC0194-0499

L/h

Vz/FSD: Apparent volume of distribution of NNC0194-0499 in the terminal phase

MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration

Hours

Full Information

NCT ID

NCT04722653

First Posted

January 21, 2021

Last Updated

April 4, 2022

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04722653

Brief Title

A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men

Official Title

Investigation of Safety, Tolerability and Pharmacokinetic Properties of Single Subcutaneous Doses of NNC0194-0499 in Japanese and Non-Asian Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

February 2, 2021 (Actual)

Primary Completion Date

April 27, 2021 (Actual)

Study Completion Date

April 27, 2021 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men. Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499. Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach. The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights). The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.

6. Conditions and Keywords

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

Non-alcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

The present trial is split into two parts reflecting the two trial populations: Japanese subjects and non-Asian subjects. For the Japanese part, it is designed as a randomised, placebo-controlled, double-blinded within cohorts, parallel group, single-dose trial. The non-Asian part is run in parallel to the Japanese part in an open design

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The non-Asian part is run in parallel to the Japanese part in an open design. The Japanese part is double-blinded. Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NN0194-0499

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo.

Intervention Type

Drug

Intervention Name(s)

NNC0194-0499

Intervention Description

1 single dose administered subcutaneously (s.c. - under the skin)

Intervention Type

Drug

Intervention Name(s)

Placebo (NNC0194-0499 )

Intervention Description

1 single dose administered subcutaneously (s.c. - under the skin).

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events (TEAEs)

Description

Count of events

Time Frame

From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36)

Secondary Outcome Measure Information:

Title

AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration

Description

h·nmol/L

Time Frame