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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070510
• Other study ID #: NN9924-4065
• Secondary ID: 2013-001087-39U1
• Status: Completed
• Phase: Phase 1
• Start date: February 27, 2014
• Est. completion date: August 20, 2014

Study information

• Verified date: February 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 20, 2014
• Est. primary completion date: August 20, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Bækdal TA, Borregaard J, Hansen CW, Thomsen M, Anderson TW. Effect of Oral Semaglutide on the Pharmacokinetics of Lisinopril, Warfarin, Digoxin, and Metformin in Healthy Subjects. Clin Pharmacokinet. 2019 Sep;58(9):1193-1203. doi: 10.1007/s40262-019-00756-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Maximum observed S-warfarin plasma concentration		0 to 168 hours after single dose
Secondary	Maximum observed R-warfarin plasma concentration		0 to 168 hours after single dose
Secondary	Maximum observed lisinopril plasma concentration		0 to 60 hours after single dose

External Links

•   Clinical Trials at Novo Nordisk