Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve
Measured in hour\*nanomoles per liter (h\*nmol/L).
From 0 to 24 hours after dosing on day 80 and 90

Secondary Outcomes (3)

Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration
From 0 to 24 hours after dosing on day 80 and 90
Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration
From 0 to 24 hours after dosing on day 80 and 90
t½,sema; the terminal half-life of semaglutide
From 0 to 840 hours after dosing on day 90

Study Arms (2)

Sequence 1: Semaglutide J then Semaglutide K

EXPERIMENTAL

Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2.

Drug: Semaglutide

Sequence 2: Semagultide K then Semaglutide J

EXPERIMENTAL

Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2.

Drug: Semaglutide

Interventions

SemaglutideDrug

Oral administration

Sequence 1: Semaglutide J then Semaglutide KSequence 2: Semagultide K then Semaglutide J

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 64 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening.
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.

Sponsors & Collaborators

Novo Nordisk A/S
Industrylead

Study Sites (1)

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

MeSH Terms

Interventions

semaglutide

Study Officials

Clinical Transparency (dept. 2834)
Novo Nordisk A/S
STUDY DIRECTOR

Enrollment

121 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

September 28, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Sequence 1: Semaglutide J then Semaglutide K

Sequence 2: Semagultide K then Semaglutide J

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Sequence 1: Semaglutide J then Semaglutide K

Sequence 2: Semagultide K then Semaglutide J

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations