drugset / Trial / NCT02016911
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild, moderate and severe degrees of hepatic impairment compared to subjects with normal hepatic function.
Timeline
- Start
- 2013-12-12
- Primary completion
- 2015-01-12
- Completion
- 2015-01-12
Publications
- Results Baekdal TA, Thomsen M, Kupcova V, Hansen CW, Anderson TW. Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment. J Clin Pharmacol. 2018 Oct;58(10):1314-1323. doi: 10.1002/jcph.1131. Epub 2018 Apr 25.
- Overgaard RV, Navarria A, Ingwersen SH, Baekdal TA, Kildemoes RJ. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials. Clin Pharmacokinet. 2021 Oct;60(10):1335-1348. doi: 10.1007/s40262-021-01025-x. Epub 2021 May 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Semaglutide | Peptide | 10 mg | Oral |