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Protein-based Tablets

Sequence 4 for Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 to 24 hours after dose administration on visit 2, day 10
Awards & highlights

Study 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.

Eligible Conditions
  • Healthy Volunteers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 to 24 hours after dose administration on visit 2, day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 0 to 24 hours after dose administration on visit 2, day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
Secondary outcome measures
Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434
tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434

Trial Design

6Treatment groups
Experimental Treatment
Group I: Sequence 6Experimental Treatment2 Interventions
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).
Group II: Sequence 5Experimental Treatment2 Interventions
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).
Group III: Sequence 4Experimental Treatment2 Interventions
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).
Group IV: Sequence 3Experimental Treatment2 Interventions
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).
Group V: Sequence 2Experimental Treatment2 Interventions
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).
Group VI: Sequence 1Experimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NNC0385-0434 F
2022
Completed Phase 1
~160
NNC0385-0434 G
2022
Completed Phase 1
~160
NNC0385-0434 B
2022
Completed Phase 1
~540

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,877 Total Patients Enrolled
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,852 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
2022. "A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05333107.
~51 spots leftby Apr 2025
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