Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy; Diabetes
• Interventions: Drug: semaglutide; Drug: metformin; Drug: digoxin; Drug: placebo

• Registration Number: NCT02249910
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the influence of oral semaglutide on pharmacokinetics (the exposure of the trial drug in the body) of metformin and digoxin in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-18
• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-23
• Study First Posted: 2014-09-26
• Primary Completion: 2015-03-06
• Study Completion: 2015-03-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Male or female, age 18-75 years (both inclusive) at the time of signing inform consent
• Body mass index (BMI) 20.0-29.9 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. 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 Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
• Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit a repeated measurement is allowed
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Semaglutide	placebo	-
Semaglutide	semaglutide	-
Semaglutide	metformin	-
Semaglutide	digoxin	-

Primary Outcome Measures

Name	Time	Method
Area under the metformin plasma concentration-time curve	During a dosing interval (0 to12 hours) at steady state
Area under the digoxin plasma concentration-time curve	From time 0 to infinity after single dose

Secondary Outcome Measures

Name	Time	Method
Maximum observed metformin plasma concentration	During a dosing interval (0 to 12 hours) at steady state
Maximum observed digoxin plasma concentration	0 to 120 hours after single dose
Maximum observed semaglutide plasma concentration	During a dosing interval (0 to 24 hours) at steady state
Area under the SNAC plasma concentration-time curve	During a dosing interval (0 to 24 hours) at steady state
Number of hypoglycaemic episodes	From the first dosing (Day 1) and until completion of the post treatment follow up visit (Day 118-122)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany