NCT01619345

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

June 12, 2012

Last Update Submit

February 20, 2015

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (1)

  • Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE)

    Assessed 0-4 hours post dose

Secondary Outcomes (4)

  • 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

    Assessed 0-4 hours post dose

  • Time to CTE

    Assessed 0-4 hours post dose

Study Arms (2)

Period 1: NN9924 with 50 mL water

EXPERIMENTAL
Drug: semaglutide

Period 2: NN9924 with 240 mL water

EXPERIMENTAL
Drug: semaglutide

Interventions

semaglutideDRUG

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.

Also known as: NN9924
Period 1: NN9924 with 50 mL waterPeriod 2: NN9924 with 240 mL water

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Nottingham, NG11 6JS, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 14, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 23, 2015

Record last verified: 2015-02

Locations

GB(1)