A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Healthy
• Interventions: Drug: NN9925 (oral); Drug: NN9925 (i.v.); Drug: placebo

• Registration Number: NCT01087645
• 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 NN9925 in healthy male subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-12
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2010-09-16
• Study Completion: 2010-09-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

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

Inclusion Criteria

• Male subjects with good general health as judged by the physician
• Body weight of 65-95 kg (both inclusive)
• Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive)

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 physician
• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial part 1	NN9925 (oral)	-
Trial part 1	placebo	-
Trial part 2	placebo	-
Trial part 2	NN9925 (i.v.)	-
Trial part 2	NN9925 (oral)	-

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 NN9925	from 0 to 504 hours

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Nottingham, United Kingdom