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

NCT02070510 | Completed Phase 1

• 3 other identifiers: NN9924-40652013-001087-39U1111-1140-3741
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• Maximum observed S-warfarin plasma concentration

  0 to 168 hours after single dose

• Maximum observed R-warfarin plasma concentration

  0 to 168 hours after single dose

• Maximum observed lisinopril plasma concentration

  0 to 60 hours after single dose

Study Arms (1)

Victim and perpetrator compounds

EXPERIMENTAL

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; Drug: lisinopril; Drug: warfarin; Drug: placebo

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.

Victim and perpetrator compounds

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).

Victim and perpetrator compounds

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).

Victim and perpetrator compounds

placebo DRUG

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

Victim and perpetrator compounds

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Location

Related Publications (1)

• Baekdal 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.

  PMID: 30945118 BACKGROUND

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide; Lisinopril; Warfarin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: February 27, 2014
• Primary Completion: August 20, 2014
• Study Completion: August 20, 2014
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

DE (1)