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

NCT05333107 | Completed Phase 1 FDA Drug

• 2 other identifiers: NN9501-4869U1111-1271-3953
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers; High Cholesterol

Outcome Measures

Primary Outcomes (1)

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

  Measured in h \* nmol/L

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (6)

Sequence 1

EXPERIMENTAL

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).

Drug: NNC0385-0434 G; Drug: NNC0385-0434 B

Sequence 2

EXPERIMENTAL

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).

Drug: NNC0385-0434 G; Drug: NNC0385-0434 F

Sequence 3

EXPERIMENTAL

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).

Drug: NNC0385-0434 F; Drug: NNC0385-0434 B

Sequence 4

EXPERIMENTAL

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).

Drug: NNC0385-0434 G; Drug: NNC0385-0434 F

Sequence 5

EXPERIMENTAL

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).

Drug: NNC0385-0434 G; Drug: NNC0385-0434 B

Sequence 6

EXPERIMENTAL

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).

Drug: NNC0385-0434 F; Drug: NNC0385-0434 B

Interventions

NNC0385-0434 G DRUG

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).

Sequence 1; Sequence 2; Sequence 4; Sequence 5

NNC0385-0434 F DRUG

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).

Sequence 2; Sequence 3; Sequence 4; Sequence 6

NNC0385-0434 B DRUG

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).

Sequence 1; Sequence 3; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Altasciences

Cypress, California, 90630, United States

Location

Altasciences Clinical Los Angeles, Inc.

Los Angeles, California, 90630, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 18, 2022
• Study Start: April 12, 2022
• Primary Completion: July 22, 2022
• Study Completion: September 23, 2022
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)