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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy
• Interventions: Drug: NN9924 (oral); Drug: placebo; Drug: NN9924 (s.c.); Drug: NN9924 (i.v.)

• Registration Number: NCT01037582
• 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 and bioavailability (exploring absorption of drug in body) of NN9924 in healthy male subjects.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2009-12-17
• Study First Submitted: 2009-12-21
• Study First Submitted QC: 2009-12-21
• Study First Posted: 2009-12-23
• Primary Completion: 2010-05-07
• Study Completion: 2010-05-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 155

Inclusion Criteria

• Male subjects with good general health as judged by the Investigator
• Body weight of 65.0-95.0 kg (both inclusive)
• Body Mass Index (BMI) of 18.5-27.5 kg/m^2 (both inclusive)

Read More

Exclusion Criteria

• Known or suspected allergy to trial product or related products
• Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the Investigator
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitits), as judged by the Investigator

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial part 1	placebo	-
Trial part 1	NN9924 (oral)	-
Trial part 2	NN9924 (oral)	-
Trial part 2	placebo	-
Trial part 2	NN9924 (s.c.)	-
Trial part 2	NN9924 (i.v.)	-

Primary Outcome Measures

Name	Time	Method
Number and severity of adverse events (AEs) recorded	from dosing to Day 22

Secondary Outcome Measures

Name	Time	Method
The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound	from 0 to 504 hours

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Harrow, United Kingdom