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

Healthy Clinical Trial

Official title:

An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02243098
• Other study ID #: NN9535-3818
• Secondary ID: 2013-001288-22U1
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2014
• Last updated: March 31, 2017
• Start date: September 16, 2014
• Est. completion date: April 7, 2015

Study information

• Verified date: March 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: April 7, 2015
• Est. primary completion date: April 7, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• 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.
• digoxin
Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.
• atorvastatin
Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Hausner H, Derving Karsbøl 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 Mar 27. doi: 10.1007/s40262- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the atorvastatin plasma concentration-time curve		From time 0 to 72 hours after a single dose
Primary	Area under the digoxin plasma concentration-time curve		From time 0 to 120 hours after a single dose
Secondary	Maximum observed atorvastatin plasma concentration		From time 0 to 72 hours after a single dose
Secondary	Maximum observed digoxin plasma concentration		From time 0 to 120 hours after a single dose
Secondary	Number of treatment emergent AEs (TEAEs)		From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline)

External Links

•   Clinical Trials at Novo Nordisk