Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01619345
First received: June 12, 2012
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
Drug: NN9924
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Anatomical location (stomach or proximal small bowel) of tablet at complete tablet erosion (CTE) [ Time Frame: Assessed 0-4 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the NN9924 concentration curve [ Time Frame: From time 0-24 hours ] [ Designated as safety issue: No ]
  • Anatomical location of initial tablet erosion (ITE) [ Time Frame: Assessed 0-4 hours post dose ] [ Designated as safety issue: No ]
  • Time to ITE [ Time Frame: Assessed 0-4 hours post dose ] [ Designated as safety issue: No ]
  • Time to CTE [ Time Frame: Assessed 0-4 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: June 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 1: NN9924 with 50 mL water Drug: NN9924
Subjects will be treated with two single doses of 10 mg NN9924 in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.
Experimental: Period 2: NN9924 with 240 mL water Drug: NN9924
Subjects will be treated with two single doses of 10 mg NN9924 in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619345

Locations
United Kingdom
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tine Aggerholm Bækdal Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01619345     History of Changes
Other Study ID Numbers: NN9924-3957, 2011-004162-14, U1111-1123-7450
Study First Received: June 12, 2012
Last Updated: September 26, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory

ClinicalTrials.gov processed this record on September 16, 2014