drugset / Trial / NCT02775955
PK Study of Intranasal RX0041-002 in Subjects With Severe Renal Impairment and Normal Renal 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 renal impairment on the systemic pharmacokinetics of acute Intranasal RX0041-002. The secondary objective is to evaluate the safety and tolerability of acute Intranasal RX0041-002 in subjects with normal renal function and severe renal impairment.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-07
- Completion
- 2016-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cocaine | Small molecule | 160 mg | Intranasal |
Indications
No indication recorded.