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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: placebo; Drug: warfarin; Drug: lisinopril; Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02070510

U1111-1140-3741 (Other Identifier)

NN9924-4065

2013-001087-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Victim and perpetrator compounds

Experimental group

Description:

Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period.

Treatment:

Drug: placebo

Drug: semaglutide

Drug: lisinopril

Drug: warfarin