Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

NCT ID: NCT01619345

Last Updated: 2015-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Period 1: NN9924 with 50 mL water

Group Type EXPERIMENTAL

semaglutide

Intervention Type 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 2: NN9924 with 240 mL water

Group Type EXPERIMENTAL

semaglutide

Intervention Type 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.

Interventions

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semaglutide

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.

Intervention Type DRUG

Other Intervention Names

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NN9924

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2011-004162-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1123-7450

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-3957

Identifier Type: -

Identifier Source: org_study_id

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