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Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2, Healthy

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

NNC0113-0987

placebo

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood assessments at the screening visit
Body mass index (BMI) above or equal to 18.5 and below 30 kg/m^ 2

Exclusion Criteria:

Male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication
Participation in another trial within 90 days prior to screening
Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator
Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
History of acute idiopathic or chronic pancreatitis

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC0113-0987

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

Number and severity of hypoglycaemic episodes

AUC, the area under the NNC0113-0987 plasma concentration-time curve

Cmax, the maximum plasma concentration of NNC0113-0987

tmax, the time to maximum plasma concentration of NNC0113-0987

Full Information

NCT ID

NCT01690169

First Posted

September 7, 2012

Last Updated

February 24, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01690169

Brief Title

Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

Official Title

Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

September 14, 2012 (Actual)

Primary Completion Date

December 11, 2012 (Actual)

Study Completion Date

December 11, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 in healthy male subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC0113-0987

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

NNC0113-0987

Intervention Description

A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

A single dose of oral placebo administered.

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events (TEAEs)

Time Frame

From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

Secondary Outcome Measure Information:

Title

Number and severity of hypoglycaemic episodes

Time Frame

From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)

Title

AUC, the area under the NNC0113-0987 plasma concentration-time curve

Time Frame

From dosing visit to infinity

Title

Cmax, the maximum plasma concentration of NNC0113-0987

Time Frame

From dosing visit until last PK sampling visit (e.g. day 11)

Title

tmax, the time to maximum plasma concentration of NNC0113-0987

Time Frame

From dosing visit until last PK sampling visit (e.g. day 11)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood assessments at the screening visit Body mass index (BMI) above or equal to 18.5 and below 30 kg/m^ 2 Exclusion Criteria: Male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication Participation in another trial within 90 days prior to screening Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies History of acute idiopathic or chronic pancreatitis

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR,1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Nottingham

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

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