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Completed

NCT Number: NCT02243098

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Digoxin

Drug

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

atorvastatin

Drug

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

Primary outcomes

  1. Area under the atorvastatin plasma concentration-time curve

    Time frame: From time 0 to 72 hours after a single dose

  2. Area under the digoxin plasma concentration-time curve

    Time frame: From time 0 to 120 hours after a single dose

Secondary outcomes

  1. Maximum observed atorvastatin plasma concentration

    Time frame: From time 0 to 72 hours after a single dose

  2. Maximum observed digoxin plasma concentration

    Time frame: From time 0 to 120 hours after a single dose

  3. Number of treatment emergent AEs (TEAEs)

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2014
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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