drugset / Trial / NCT02313103
Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects
Phase 1
Completed
16 enrolled
USWM, LLC (dba US WorldMeds)
National Institute on Drug Abuse (NIDA) · collab
Non-randomizedParallel-groupOpen-labelBasic science
Summary
This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1 matches to each ESRD subjects, matched for gender, age, and BMI.
Timeline
- Start
- 2014-11
- Primary completion
- 2015-02
- Completion
- 2015-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lofexidine | Small molecule | 400 ug | Oral |
Indications
No indication recorded.