Safety of NNC 0123-0000-0338 in Healthy Subjects

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: NNC 0123-0000-0338; Drug: placebo; Drug: insulin glargine

• Registration Number: NCT01334034
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as tablets in healthy subjects.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04-11
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Primary Completion: 2011-09-16
• Study Completion: 2011-09-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

• Male subject
• Body mass index (BMI) between 18 and 28 kg/m^2 (both inclusive)

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Exclusion Criteria

• Known or suspected hypersensitivity to trial products or related products
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the trial physician
• Presence of any medical condition that may confound the results of the trial or pose an unacceptable risk to the subject by administering the trial product, as judged by the trial physician

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose levels 1-7	NNC 0123-0000-0338	-
Dose levels 1-7	placebo	-
Dose levels 1-7	insulin glargine	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events	from trial product administration and until completion of the dosing visit (Day 0 to Day 6)

Secondary Outcome Measures

Name	Time	Method
Area under the serum insulin concentration-time curve	from 0 to 120 hours after a single dose
Area under the glucose infusion rate-time curve	from 0 to 24 hours after a single dose

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Neuss, Germany