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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

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

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

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