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

NCT02243098 | Completed Phase 1

• 3 other identifiers: NN9535-38182013-001288-22U1111-1140-8551
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Area under the atorvastatin plasma concentration-time curve

  From time 0 to 72 hours after a single dose

• Area under the digoxin plasma concentration-time curve

  From time 0 to 120 hours after a single dose

Secondary Outcomes (3)

• Maximum observed atorvastatin plasma concentration

  From time 0 to 72 hours after a single dose

• Maximum observed digoxin plasma concentration

  From time 0 to 120 hours after a single dose

• Number of treatment emergent AEs (TEAEs)

  From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline)

Study Arms (1)

Semaglutide

EXPERIMENTAL

Drug: semaglutide; Drug: digoxin; Drug: atorvastatin

Interventions

semaglutide 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.

Semaglutide

digoxin DRUG

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

Semaglutide

atorvastatin DRUG

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

Semaglutide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• 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.

  PMID: 28349387 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide; Digoxin; Atorvastatin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 17, 2014
• Study Start: September 16, 2014
• Primary Completion: April 7, 2015
• Study Completion: April 7, 2015
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

DE (1)