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

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 18, 2014

Primary Completion Date

March 6, 2015

Study Completion Date

March 6, 2015

Conditions
DiabetesHealthy
Interventions
DRUG

semaglutide

Oral administration of 5 mg daily for one week, then escalated to 10 mg daily for one week, followed by escalation to 20 mg daily for 41 days

DRUG

metformin

Oral administration of 850 mg twice daily for 3 days followed by 850 mg on day 4, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) and 3) co-administration with oral semaglutide.

DRUG

digoxin

Oral administration of 0.5 mg single dose, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-\[8-(2-hydroxybenzoyl) amino\] caprylate) and 3) co-administration with oral semaglutide.

DRUG

placebo

Oral administration of SNAC 300 mg. Will be administered with the morning dose of metformin (1st, 3rd, 5th and 7th dose). On Day 24, a single SNAC dose will be administered with digoxin.

Trial Locations (1)

14050

Novo Nordisk Investigational Site, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT02249910 - Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Metformin and Digoxin in Healthy Subjects | Biotech Hunter | Biotech Hunter