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A Two Part Trial Investigating the Safety of NN9924 in Healthy Male Subjects

NCT01037582 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2019-01-03

No results posted yet for this study

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9924 in healthy male subjects.

Conditions

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy

Interventions

DRUG

NN9924 (oral)

Subjects will be randomized to receive a single dose of NN9924, at escalating dose levels. Progression to next dose will be based on safety evaluation.

DRUG

placebo

Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.

DRUG

NN9924 (oral)

Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.

DRUG

placebo

Subjects will be randomized to receive a single dose of placebo.

DRUG

NN9924 (s.c.)

As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit

DRUG

NN9924 (i.v.)

As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.

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
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-17
Primary Completion
2010-05-07
Completion
2010-05-07

Countries

  • United Kingdom

Study Locations

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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 NCT01037582 on ClinicalTrials.gov