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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037582
• Other study ID #: NN9924-3691
• Secondary ID: 2009-012366-31U1
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2009
• Est. completion date: May 7, 2010

Study information

• Verified date: January 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: May 7, 2010
• Est. primary completion date: May 7, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Healthy

Intervention

Drug:
• NN9924 (oral)
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
Subjects will receive a single dose of placebo as a comparator to NN9924, at all dose levels.
• NN9924 (oral)
Subjects will be randomized to receive a single dose of NN9924 in one of three different concentrations. The dose will be selected based on the results of part 1.
• placebo
Subjects will be randomized to receive a single dose of placebo.
• NN9924 (s.c.)
As an active comparator, one standard dose will be given s.c. (under the skin) at one study visit
• NN9924 (i.v.)
As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit.

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and severity of adverse events (AEs) recorded		from dosing to Day 22
Secondary	The uptake in blood of oral NN9924 compared to i.v. and s.c. administration of the same compound		from 0 to 504 hours

External Links

•   Clinical Trials at Novo Nordisk