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A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects

NCT01597713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2015-05-29

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, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers.

The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.

Conditions

  • Diabetes
  • Diabetes Mellitus, Type 2
  • Healthy

Interventions

DRUG

NNC 0148-0000-0362

Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group

DRUG

insulin glargine

As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group

DRUG

placebo

Subjects will receive a single dose of oral placebo within each dose group

DRUG

NNC 0148-0000-0362

Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period

DRUG

NNC 0148-0000-0362

Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period

DRUG

NNC 0148-0000-0362

Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period

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
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Germany

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 NCT01597713 on ClinicalTrials.gov