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

NCT02304627 | Completed Phase 1

• 3 other identifiers: NN1953-39742014-000979-87U1111-1154-0535
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• Area under the serum insulin 338 concentration-time curve

  From 0 to 288 hours after a single dose (SD)

• Maximum observed serum insulin 338 concentration

  From 0 to 288 hours after a single dose (SD)

• Area under the plasma capric acid concentration-time curve

  From 0 to 24 hours after a single dose

• Maximum observed plasma capric acid concentration

  From 0 to 24 hours after a single dose

Study Arms (4)

Eating meal immediately after dosing

EXPERIMENTAL

Drug: insulin 338 (GIPET I)

Eating meal 30 min after dosing

EXPERIMENTAL

Drug: insulin 338 (GIPET I)

Eating meal 1 hour after dosing

EXPERIMENTAL

Drug: insulin 338 (GIPET I)

Eating meal 6 hour after dosing

EXPERIMENTAL

Drug: insulin 338 (GIPET I)

Interventions

insulin 338 (GIPET I) DRUG

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.

Eating meal 1 hour after dosing; Eating meal 30 min after dosing; Eating meal 6 hour after dosing; Eating meal immediately after dosing

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

• Halberg IB, Lyby K, Wassermann K, Heise T, Plum-Morschel L, Zijlstra E. The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects. Clin Pharmacokinet. 2019 Nov;58(11):1497-1504. doi: 10.1007/s40262-019-00772-2.

  PMID: 31093929 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine 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: November 21, 2014
• First Posted: December 2, 2014
• Study Start: November 24, 2014
• Primary Completion: July 31, 2015
• Study Completion: July 31, 2015
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

DE (1)