Pharmacoscintigraphic Investigation of NN9924 in Healthy... | NCT01619345

Studies
Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

NCT01619345

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 23, 2015Estimated

Enrollment

27Actual

Phase

Phase 1

Conditions

Diabetes
Healthy

Interventions

semaglutide

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-004162-14	EudraCT Number
U1111-1123-7450	Other Identifier	WHO

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Jun 12, 2012

First Posted Date

Jun 14, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2015

Last Update Posted Date

Feb 23, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Period 1: NN9924 with 50 mL water	Experimental		Drug: semaglutide
Period 2: NN9924 with 240 mL water	Experimental		Drug: semaglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semaglutide	Drug	Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.	Period 1: NN9924 with 50 mL water

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)		Assessed 0-4 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Area under the NN9924 concentration curve		From time 0-24 hours
Anatomical location of initial tablet erosion (ITE)		Assessed 0-4 hours post dose
Time to ITE

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Good general health
Body mass index (BMI) of 18.5-30.0 kg/m^2 (both inclusive)

Exclusion Criteria:

Males who are not willing to use two acceptable forms of highly effective contraception
Participation in another clinical trial within 90 days
Any chronic disorder or severe disease
Use of GLP-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing
Subjects who are smokers
Subjects who have donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Nottingham		NG11 6JS	United Kingdom

Label	URL
Clinical Trials at Novo Nordisk	View source

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000591245	semaglutide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided