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A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II

Primary Purpose

Healthy Volunteers; High Cholesterol

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NNC0385-0434 G

NNC0385-0434 F

NNC0385-0434 B

About this trial

This is an interventional treatment trial for Healthy Volunteers; High Cholesterol

Eligibility Criteria

18 Years - 64 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male
Aged 18-64 years (both inclusive) at the time of signing informed consent
Body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive)
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:

Known or suspected hypersensitivity to study interventions or related products
Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening
Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol
Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
History of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

Sites / Locations

Novo Nordisk Investigational Site
Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Arm Description

Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).

Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).

Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).

Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).

Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).

Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).

Outcomes

Primary Outcome Measures

AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval

Measured in h * nmol/L

Secondary Outcome Measures

Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434

Measured in nmol/L

tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434

Measured in hours

Full Information

NCT ID

NCT05333107

First Posted

April 11, 2022

Last Updated

July 7, 2023

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT05333107

Brief Title

A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II

Official Title

A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

April 12, 2022 (Actual)

Primary Completion Date

July 22, 2022 (Actual)

Study Completion Date

September 23, 2022 (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

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.

6. Conditions and Keywords

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

Healthy Volunteers; High Cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).

Arm Title

Sequence 3

Arm Type

Experimental

Arm Description

Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).

Arm Title

Sequence 4

Arm Type

Experimental

Arm Description

Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).

Arm Title

Sequence 5

Arm Type

Experimental

Arm Description

Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).

Arm Title

Sequence 6

Arm Type

Experimental

Arm Description

Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).

Intervention Type

Drug

Intervention Name(s)

NNC0385-0434 G

Intervention Description

Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).

Intervention Type

Drug

Intervention Name(s)

NNC0385-0434 F

Intervention Description

Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).

Intervention Type

Drug

Intervention Name(s)

NNC0385-0434 B

Intervention Description

Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).

Primary Outcome Measure Information:

Title

AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval

Description

Measured in h * nmol/L

Time Frame

From 0 to 24 hours after dose administration on visit 2, day 10

Secondary Outcome Measure Information:

Title

Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434

Description

Measured in nmol/L

Time Frame

From 0 to 24 hours after dose administration on visit 2, day 10

Title

tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434

Description

Measured in hours

Time Frame

From 0 to 24 hours after dose administration on visit 2, day 10

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male Aged 18-64 years (both inclusive) at the time of signing informed consent Body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive) 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: Known or suspected hypersensitivity to study interventions or related products Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator History of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

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

Cypress

State/Province

California

ZIP/Postal Code

90630

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90630

Country

United States

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

Learn more about this trial

A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II

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