Skip to content

Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT02243098 (opens ClinicalTrials.gov in a new tab)Other idNN9535-3818Other id2013-001288-22Other idU1111-1140-8551

Overview

Status
Completed
Phase
Phase 1
Enrollment
31 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Germany

Start
16 Sept 2014
Primary completion
7 Apr 2015
Completion
7 Apr 2015
First posted
17 Sept 2014 (estimated)
Last update posted
4 Apr 2017
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 1

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

    NCT02243098

    16 Sept 2014 to 7 Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • semaglutideDrug
  • digoxinDrug
  • atorvastatinDrug

Arms1

  • Experimental

    Semaglutide

Primary outcomes2

Outcomes the sponsor listed as primary.

  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(3)
  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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2017

7 results

Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects.

Hausner et al. 2017Clinical pharmacokineticscited by 51

PMID 28349387PMC5648738DOI 10.1007/s40262-017-0532-6PUB-28349387

Free to read · publisher termsCC BY-NC7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.