drugset / Trial / NCT01240967
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function
Non-randomizedOpen-label
Summary
The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.
Timeline
- Start
- 2010-11
- Primary completion
- 2011-07
- Completion
- 2011-07
Publications
- Alverlind S, Barassin S, Dalen P, Li Y, Toler S, Eriksson H, Tummala R. Clinical pharmacokinetics of the nicotinic channel modulator dexmecamylamine (TC-5214) in subjects with various degrees of renal impairment. Clin Drug Investig. 2014 Jul;34(7):457-65. doi: 10.1007/s40261-014-0195-0.
- Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | dexmecamylamine | Other / unclassified | 2 mg | Oral |
| Subject | dexmecamylamine | Other / unclassified | 8 mg | Oral |