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Trial · Interventional

CompletedPhase 1Registry data

A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

NCTNCT02070510 (opens ClinicalTrials.gov in a new tab)Other idNN9924-4065Other id2013-001087-39Other idU1111-1140-3741

Overview

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

Germany

Start
27 Feb 2014
Primary completion
20 Aug 2014
Completion
20 Aug 2014
First posted
25 Feb 2014 (estimated)
Last update posted
17 Feb 2020
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 1

    A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

    NCT02070510

    27 Feb 2014 to 20 Aug 2014

Registry summary

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

This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy subjects.

Interventions

  • semaglutideDrug
  • lisinoprilDrug
  • warfarinDrug
  • placeboDrug

Arms1

  • Experimental

    Victim and perpetrator compounds

    Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Area under the S-warfarin concentration-time curve

    Time frame · From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points

  2. Area under the R-warfarin concentration-time curve

    Time frame · From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points

  3. Area under the lisinopril concentration-time curve

    Time frame · From dosing to infinity calculated from a 0-60 hours lisinopril concentration-time-curve based on 13 sampling time points

Secondary outcomes(3)
  1. Maximum observed S-warfarin plasma concentration

    Time frame · 0 to 168 hours after single dose

  2. Maximum observed R-warfarin plasma concentration

    Time frame · 0 to 168 hours after single dose

  3. Maximum observed lisinopril plasma concentration

    Time frame · 0 to 60 hours after single dose

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 · 2019

6 results

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

Bækdal et al. 2019Clinical pharmacokineticscited by 52

PMID 30945118PMC6719321DOI 10.1007/s40262-019-00756-2PUB-30945118

Free to read · publisher termsCC BY-NC6 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female aged 18-75 years (both inclusive) at time of signing informed consent * Body mass index 20.0-29.9 kg/m\^2 (both inclusive) * A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices) * History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease * Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit, a repeated measurement is allowed * Any blood draw in excess of 50 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening

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