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A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

Primary Purpose

Non-alcoholic Steatohepatitis (NASH)

Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
NNC0194-0499
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Steatohepatitis (NASH)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 18.5-39.9 kilogram per meter square (kg/m2) (both inclusive). Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to Kidney Disease: Improving Global Outcomes (KDIGO) 20121, 2 standardized to the individual body surface area (BSA). Group description eGFR (mL/min) Normal renal function greater than or equal to 90 Mild renal impairment 60 - 89 Moderate renal impairment 30 - 59 Severe renal impairment 15 - 29 not requiring dialysis End-Stage Renal Disease (ESRD) less than 15 or requiring dialysis treatment Renal group 5 (ESRD). Participants requiring dialysis treatment should be on treatment with haemodialysis. Exclusion Criteria: Any disorder, except for conditions associated with renal impairment, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening. Use of the following are allowed: Routine vitamins, occasional use of paracetamol, ibuprofen and topical medication not reaching systemic circulation. Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP). Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).

Sites / Locations

  • Novo Nordisk Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Participants with normal renal function

Participants with impaired renal function

Arm Description

Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.

Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.

Outcomes

Primary Outcome Measures

AUC0499,0-∞,SD: Area under the NNC0194-0499 serum concentration-time curve after a single dose
Measured as hours*nanomoles per litre (h*nmol/L)

Secondary Outcome Measures

Cmax,0499,SD: Maximum observed serum NNC0194-0499 concentration after a single dose
Measured as nanomoles per litre (nmol/L)
tmax,0499,SD: Time to maximum observed serum NNC0194-0499 concentration after a single dose
Measured in hours (h)
t½,0499,SD: Terminal half-life of NNC0194-0499 after a single dose
Measured in hours (h)
Vz/F0499,SD: Apparent volume of distribution of NNC0194-0499 after a single dose
Measured as Litre (L)
CL/F0499,SD: Apparent clearance of NNC0194-0499 after a single dose
Measured as Litre per hour (L/h)
CLR,0499,SD: Renal clearance of NNC0194-0499 after a single dose
Measured as Litre per hour (L/h)

Full Information

First Posted
February 5, 2023
Last Updated
July 27, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05727644
Brief Title
A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
Official Title
Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0194-0499 in Participants With Various Degrees of Renal Impairment and Normal Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
February 21, 2024 (Anticipated)
Study Completion Date
February 21, 2024 (Anticipated)

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
Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver. In this study the blood and urine levels of NNC0194-0499 will be compared in people with various degrees of reduced kidney function to the blood and urine levels in people with normal kidney function, after administration of one dose of 30 milligrams (mg) NNC0194-0499. Participant will only get the study medicine in one injection into a skinfold in the thigh (subcutaneous). The study will last for about 66 days including a screening phase of up to 28 days prior to dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Steatohepatitis (NASH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with normal renal function
Arm Type
Active Comparator
Arm Description
Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.
Arm Title
Participants with impaired renal function
Arm Type
Experimental
Arm Description
Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.
Intervention Type
Drug
Intervention Name(s)
NNC0194-0499
Intervention Description
Participants will receive a single subcutaneous injection of 30 mg NNC0194-0499.
Primary Outcome Measure Information:
Title
AUC0499,0-∞,SD: Area under the NNC0194-0499 serum concentration-time curve after a single dose
Description
Measured as hours*nanomoles per litre (h*nmol/L)
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Secondary Outcome Measure Information:
Title
Cmax,0499,SD: Maximum observed serum NNC0194-0499 concentration after a single dose
Description
Measured as nanomoles per litre (nmol/L)
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Title
tmax,0499,SD: Time to maximum observed serum NNC0194-0499 concentration after a single dose
Description
Measured in hours (h)
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Title
t½,0499,SD: Terminal half-life of NNC0194-0499 after a single dose
Description
Measured in hours (h)
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Title
Vz/F0499,SD: Apparent volume of distribution of NNC0194-0499 after a single dose
Description
Measured as Litre (L)
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Title
CL/F0499,SD: Apparent clearance of NNC0194-0499 after a single dose
Description
Measured as Litre per hour (L/h)
Time Frame
From baseline (Visit 2, Day 1, pre-dose) until completion of the end of study visit (Visit 9, Day 36)
Title
CLR,0499,SD: Renal clearance of NNC0194-0499 after a single dose
Description
Measured as Litre per hour (L/h)
Time Frame
From baseline (Visit 2, Day 1, predose) until completion of the urine collection period 96 hours after dosing (Visit 2, Day 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged 18-80 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 18.5-39.9 kilogram per meter square (kg/m2) (both inclusive). Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation according to Kidney Disease: Improving Global Outcomes (KDIGO) 20121, 2 standardized to the individual body surface area (BSA). Group description eGFR (mL/min) Normal renal function greater than or equal to 90 Mild renal impairment 60 - 89 Moderate renal impairment 30 - 59 Severe renal impairment 15 - 29 not requiring dialysis End-Stage Renal Disease (ESRD) less than 15 or requiring dialysis treatment Renal group 5 (ESRD). Participants requiring dialysis treatment should be on treatment with haemodialysis. Exclusion Criteria: Any disorder, except for conditions associated with renal impairment, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Use of prescription medicinal products or non-prescription drugs, or non-routine vitamins, which at the investigators judgement may affect participant safety or the results of the study within 14 days before screening. Use of the following are allowed: Routine vitamins, occasional use of paracetamol, ibuprofen and topical medication not reaching systemic circulation. Use of drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing of the investigational medicinal product (IMP). Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novo Nordisk
Phone
(+1) 866-867-7178
Email
clinicaltrials@novonordisk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting

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

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A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function

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