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Safety, Tolerability, and Profile of Action of Drug in the Body of NN9535 in Healthy Male Japanese and Caucasian Subjects

NCT00851773 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2015-02-23

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this clinical trial is to assess and compare the safety and tolerability, as assessed by adverse events after multiple subcutaneous doses of NN9535 in healthy male Japanese and Caucasian subjects.

Conditions

Interventions

DRUG

semaglutide

0.1 mg once weekly, s.c. injection

DRUG

semaglutide

0.2 mg once weekly, s.c. injection

DRUG

semaglutide

0.4 mg once weekly, s.c. injection

DRUG

semaglutide

0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection

DRUG

semaglutide

0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, 1.2 mg once weekly for 6 weeks, s.c. injection

DRUG

placebo

0.1 mg once weekly, s.c. injection

DRUG

placebo

0.2 mg once weekly, s.c. injection

DRUG

placebo

0.4 mg once weekly, s.c. injection

DRUG

placebo

0.4 mg once weekly for 1 week, 0.8 mg once weekly for 7 weeks, s.c. injection

DRUG

placebo

0.4 mg once weekly for 1 week, 0.8 mg once weekly for 1 week, followed by 1.2 mg once weekly injections for 6 weeks, s.c. injection

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
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United Kingdom

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Entities

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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 NCT00851773 on ClinicalTrials.gov