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Protein-based Tablets
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
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
No Placebo-Only Group
Summary
This trial is testing a new drug in different tablet forms to help men with high cholesterol. The goal is to find out which form works best to lower cholesterol levels and reduce heart disease risk.
Eligible Conditions
- Healthy Volunteers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 0 to 24 hours after dose administration on visit 2, day 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 to 24 hours after dose administration on visit 2, day 10
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
Secondary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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 G
2022
Completed Phase 1
~160
NNC0385-0434 F
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
1,557 Previous Clinical Trials
2,446,158 Total Patients Enrolled
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
40 Previous Clinical Trials
525,583 Total Patients Enrolled