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A Trial to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Male Japanese and Caucasian Subjects

NCT02161588 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2014-12-03

No results posted yet for this study

Summary

This trial is conducted in Asia. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), pharmacodynamics (the effect of the investigated drug on the body), safety and tolerability of oral semaglutide in healthy male Japanese and Caucasian subjects.

Conditions

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy

Interventions

DRUG

semaglutide

Once-daily oral administration as tablets. The dose level of oral semaglutide used in the 'Dose escalation period', 'Treatment period 1', 'Treatment period 2' and 'Treatment period 3' will be 5, 10, 20 and 40 mg per day, respectively.

DRUG

placebo

Once-daily oral administration as tablets.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161588 on ClinicalTrials.gov