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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: semaglutide; Drug: digoxin; Drug: atorvastatin

• Registration Number: NCT02243098
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-15
• Study First Submitted QC: 2014-09-15
• Study Start: 2014-09-16
• Study First Posted: 2014-09-17
• Primary Completion: 2015-04-07
• Study Completion: 2015-04-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Semaglutide	semaglutide	-
Semaglutide	atorvastatin	-
Semaglutide	digoxin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇪 Berlin, Germany