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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT02070510
Collaborator
(none)
52
1
1
5.7
9.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Feb 27, 2014
Actual Primary Completion Date :
Aug 20, 2014
Actual Study Completion Date :
Aug 20, 2014

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: semaglutide
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.

Drug: lisinopril
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).

Drug: warfarin
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).

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

Outcome Measures

Primary Outcome Measures

  1. Area under the S-warfarin concentration-time curve [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 [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 [From dosing to infinity calculated from a 0-60 hours lisinopril concentration-time-curve based on 13 sampling time points]

Secondary Outcome Measures

  1. Maximum observed S-warfarin plasma concentration [0 to 168 hours after single dose]

  2. Maximum observed R-warfarin plasma concentration [0 to 168 hours after single dose]

  3. Maximum observed lisinopril plasma concentration [0 to 60 hours after single dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Berlin Germany 14050

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT02070510
Other Study ID Numbers:
  • NN9924-4065
  • 2013-001087-39
  • U1111-1140-3741
First Posted:
Feb 25, 2014
Last Update Posted:
Feb 17, 2020
Last Verified:
Feb 1, 2020
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 17, 2020