A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects

Healthy Clinical Trial

Official title:

A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597713
• Other study ID #: NN1954-3936
• Secondary ID: 2011-005147-27U1
• Status: Completed
• Phase: Phase 1
• First received: May 10, 2012
• Last updated: May 28, 2015
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: May 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers.

The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Body mass index 18-28 kg/m^2 (both inclusive)

• Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Known or suspected hypersensitivity to trial products or related products

• Previous participation in this trial. Participation is defined as randomised

• Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator

• Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• NNC 0148-0000-0362
Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
• insulin glargine
As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
• placebo
Subjects will receive a single dose of oral placebo within each dose group
• NNC 0148-0000-0362
Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period
• NNC 0148-0000-0362
Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period
• NNC 0148-0000-0362
Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events		Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit	No
Secondary	Area under the serum insulin concentration-time curve (with Trial part 1)		From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively	No
Secondary	Area under the glucose infusion rate (GIR)-time curve (Trial part 1)		From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively	No
Secondary	Area under the serum insulin concentration-time curve (Trial part 2)		From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively	No

External Links

•   Clinical Trials at Novo Nordisk