Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: semaglutide

Drug: atorvastatin

Drug: digoxin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02243098

NN9535-3818

U1111-1140-8551 (Other Identifier)

2013-001288-22 (EudraCT Number)

Details and patient eligibility

About

The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.

Enrollment

31 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive)

Exclusion criteria

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control throughout the trial including the 5 weeks follow-up period. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal supplements, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (first dose administration)
History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
Smoking in the last 3 months prior to screening or a positive nicotine test