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Completed

NCT Number: NCT01037582

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Harrow, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

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

Treatment and study plan

NN9924 (oral)

Drug

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.

Placebo

Drug

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

NN9924 (s.c.)

Drug

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

NN9924 (i.v.)

Drug

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

Primary outcomes

  1. Number and severity of adverse events (AEs) recorded

    Time frame: from dosing to Day 22

Secondary outcomes

  1. The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound

    Time frame: from 0 to 504 hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation on Safety, Tolerability and Bioavailability of Oral NN9924 in Healthy Male Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 23, 2009
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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