A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

Condition(s) targeted: Diabetes; Healthy

Intervention: semaglutide (Drug); lisinopril (Drug); warfarin (Drug); placebo (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy subjects.

Official title: An Open-label, Single Arm, Sequential, Single Centre Trial Investigating the Influence of Oral Semaglutide (NNC0113-0217) on Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Area under the S-warfarin concentration-time curve

Area under the R-warfarin concentration-time curve

Area under the lisinopril concentration-time curve

Secondary outcome:

Maximum observed S-warfarin plasma concentration

Maximum observed R-warfarin plasma concentration

Maximum observed lisinopril plasma concentration

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

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

- Body mass index 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 50 mL in the past month, or donation of blood or plasma

in excess of 400 mL within the 3 months preceding screening

Berlin 14050, Germany

Clinical Trials at Novo Nordisk

Starting date: February 2014
Last updated: August 25, 2014