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Completed

NCT Number: NCT02070510

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

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.

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Key information

Age range

18 year–75 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 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

Treatment and study plan

semaglutide

Drug

For oral administration once daily. Doses of 5 mg and 10 mg, respectively, will be given for 7 days followed by 20 mg administered on days 43-84.

Lisinopril

Drug

For oral administration. A single dose of 20 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 1, 15 and 71).

Warfarin

Drug

For oral administration. A single dose of 5 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 8, 22 and 78).

Placebo

Drug

A single dose of SNAC is administered conconmitantly with victim compounds (days 15 and 22).

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open-label, Single Arm, Sequential, Single Centre Trial Investigating the Influence of Oral Semaglutide (NNC0113-0217) on Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 25, 2014
Registry last updated
Feb 17, 2020

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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