Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

NCT ID: NCT01272973

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

Brief Summary

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This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2 Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oral 1

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.

placebo

Intervention Type DRUG

Placebo (oral) administered once daily for 10 weeks.

Oral 2

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.

placebo

Intervention Type DRUG

Placebo (oral) administered once daily for 10 weeks.

Oral 3

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.

placebo

Intervention Type DRUG

Placebo (oral) administered once daily for 10 weeks.

S.c.

Group Type ACTIVE_COMPARATOR

semaglutide

Intervention Type DRUG

Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.

Interventions

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semaglutide

Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.

Intervention Type DRUG

placebo

Placebo (oral) administered once daily for 10 weeks.

Intervention Type DRUG

semaglutide

Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.

Intervention Type DRUG

Other Intervention Names

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NN9924

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects, based on an assessment of medical history, physical examination and
* BMI between 21 and 30 kg/m2 (21 inclusive)

Exclusion Criteria

* Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner
* Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological
* The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

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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Berlin, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1118-0257

Identifier Type: OTHER

Identifier Source: secondary_id

2010-019951-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN9924-3692

Identifier Type: -

Identifier Source: org_study_id

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