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

NCT ID: NCT02243098

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-16
• Study Completion Date: 2015-04-07

Brief Summary

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.

Conditions

Diabetes; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Semaglutide

Group Type: EXPERIMENTAL

semaglutide

Intervention Type: DRUG

Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period.

digoxin

Intervention Type: DRUG

Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.

atorvastatin

Intervention Type: DRUG

Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.

Interventions

semaglutide

Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period.

Intervention Type: DRUG

digoxin

Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.

Intervention Type: DRUG

atorvastatin

Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Berlin, , Germany

Countries

Germany

References

Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6.

Reference Type: RESULT

PMID: 28349387 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

2013-001288-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1140-8551

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-3818

Identifier Type: -

Identifier Source: org_study_id