Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Healthy Clinical Trial

Official title:

Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172313
• Other study ID #: NN9924-4154
• Secondary ID: 2013-004707-39U1
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2014
• Last updated: October 20, 2014
• Start date: June 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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 oral semaglutide, in a SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) tablet formulation with three different dosing conditions in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female subject aged 18-75 years (both inclusive) at the time of signing informed consent

• Body mass index of 18.5-29.9 kg/m^2 (both inclusive)

• A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose of oral semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)

• History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator

• Not able or not willing to refrain from smoking or use of nicotine substitute products when staying at the clinical unit

• Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening

• Previous gastrointestinal surgery such as invasive and corrective procedures involving the oesophagus, stomach, duodenum, gallbladder, pancreas or intestinal resections. Exempt are subjects that underwent uncomplicated surgical and diagnostic procedures such as appendectomy, hernia surgery, polypectomy, biopsies, as wells as colonic- and gastric endoscopy

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• semaglutide
For oral administration.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the semaglutide plasma concentration time curve		From time 0 to 24 hours after the 10th daily dose	No
Secondary	Maximum observed semaglutide plasma concentration		0 to 24 hours after the 10th daily dose	No
Secondary	Time to maximum observed semaglutide plasma concentration		0 to 24 hours after the 10th daily dose	No
Secondary	Terminal half-life of semaglutide		After the 10th daily dose	No
Secondary	Area under the SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) plasma concentration time curve		From time 0 to 24 hours after the 10th daily dose	No

External Links

•   Clinical Trials at Novo Nordisk