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Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02304627
Collaborator
(none)
45
Enrollment
1
Location
4
Arms
8.2
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects.

Condition or Disease Intervention/Treatment Phase
  • Drug: insulin 338 (GIPET I)
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects
Actual Study Start Date :
Nov 24, 2014
Actual Primary Completion Date :
Jul 31, 2015
Actual Study Completion Date :
Jul 31, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eating meal immediately after dosing

Drug: insulin 338 (GIPET I)
Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.
Experimental: Eating meal 30 min after dosing

Drug: insulin 338 (GIPET I)
Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.
Experimental: Eating meal 1 hour after dosing

Drug: insulin 338 (GIPET I)
Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.
Experimental: Eating meal 6 hour after dosing

Drug: insulin 338 (GIPET I)
Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.

Outcome Measures

Primary Outcome Measures

  1. Area under the serum insulin 338 concentration-time curve [From a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 41 sampling time points]

Secondary Outcome Measures

  1. Area under the serum insulin 338 concentration-time curve [From 0 to 288 hours after a single dose (SD)]

  2. Maximum observed serum insulin 338 concentration [From 0 to 288 hours after a single dose (SD)]

  3. Area under the plasma capric acid concentration-time curve [From 0 to 24 hours after a single dose]

  4. Maximum observed plasma capric acid concentration [From 0 to 24 hours after a single dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Age 18-64 years (both inclusive) at the time of signing informed consent

  • Body mass index 18.5-28.0 kg/m^2 (both inclusive)

  • Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial products or related products

  • Previous participation in this trial. Participation is defined as informed consent

  • Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Neuss Germany 41460

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02304627
Other Study ID Numbers:
  • NN1953-3974
  • 2014-000979-87
  • U1111-1154-0535
First Posted:
Dec 2, 2014
Last Update Posted:
Jul 8, 2019
Last Verified:
Jul 1, 2019
Additional relevant MeSH terms:
Insulin

Study Results

No Results Posted as of Jul 8, 2019