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

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ClinicalTrials.gov Identifier: NCT01087645
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Healthy Drug: NN9925 (oral) Drug: NN9925 (i.v.) Drug: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects
Actual Study Start Date : March 12, 2010
Actual Primary Completion Date : September 16, 2010
Actual Study Completion Date : September 16, 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Trial part 1 Drug: NN9925 (oral)
Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation

Drug: placebo
Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
Experimental: Trial part 2 Drug: NN9925 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit

Drug: NN9925 (oral)
Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1

Drug: placebo
Subjects will be randomised to receive a single dose of placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number and severity of adverse events (AEs) recorded [ Time Frame: from dosing to Day 22 ]

Secondary Outcome Measures :
  1. The uptake in blood of oral NN9925 [ Time Frame: from 0 to 504 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087645


Locations
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United Kingdom
Novo Nordisk Investigational Site
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01087645    
Other Study ID Numbers: NN9925-3779
2009-016975-31 ( EudraCT Number )
U1111-1113-2537 ( Other Identifier: WHO )
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases