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

Sponsor
Novo Nordisk A/S
Study ID
NCT02070510
Phase
PHASE1
Status
Completed

Conditions

  • Diabetes
  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Feb 27, 2014
Status verified
Feb 2020
Primary completion
Aug 20, 2014
Completion
Aug 20, 2014

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

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 ]

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