drugset / Trial / NCT02775981
Pharmacokinetic Study of Intranasal RX0041-002 in Hepatic-Impaired Individuals and Subjects With Normal Hepatic Function
Phase 1
Completed
24 enrolled
Pharmaceutical Project Solutions, Inc.
Cognitive Research Corporation · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to evaluate the potential effect of hepatic impairment on the systemic pharmacokinetics of RX0041-002 following single dose intranasal administration. The secondary objective is to evaluate the safety and tolerability of intranasal RX0041-002 in subjects with normal hepatic function and hepatic impairment.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-07
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cocaine | Small molecule | 160 mg | Intranasal |