NCT02325024

A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.

An Open-Label, Single-Dose Study to Compare the Pharmacokinetics (PK) of an Oromucosal Dose of Four Sprays of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease (ESRD), Not Requiring Dialysis, Compared to Matched Subjects With Normal Renal Function.

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GW Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end stage renal disease (ESRD), compared with subjects who have normal renal function. The primary clinical hypothesis is that there will be an effect from severe renal impairment on the PK of Sativex® when administered as a single oromucosal dose. The study additionally aims to evaluate the safety and tolerability of the same single oromucosal dose of Sativex® in subjects with severe renal impairment or ESRD.

Detailed description

This is a Phase I, open label, single-dose study to evaluate the effect of renal impairment on the PK of an oromucosal dose (four sprays) of Sativex® (containing 10.8 mg Δ9 tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) in subjects with severe renal impairment or ESRD (with a creatinine clearance \< 30 mL/min and not requiring dialysis) compared to matched subjects with normal renal function (with a creatinine clearance \> 80 mL/min). Eligible subjects will be given a single oromucosal dose (four sprays) of Sativex® on Dosing Day 1. Serial blood and urine samples for determination of concentrations of THC, 11-hydroxy- Δ9 - tetrahydrocannabinol (11-OH-THC), CBD, and 7-hydroxy-cannabidiol (7- OH-CBD) will be collected from subjects with severe renal impairment or ESRD, not requiring dialysis, and matched subjects with normal renal function before and up to 48 hours after dosing at selected time points. Pre-dose blood samples will also be collected for protein binding measurement. Safety and tolerability will be evaluated from Day -2 through to the post-study follow-up visit. The Follow-up Safety visit will be performed 7 days after Sativex® dosing (+ 2 days). The expected maximum duration for study participation (including Screening, Inpatient Period, and Follow-up) for each individual subject is a maximum of 24 days.

Conditions

• Renal Insufficiency
• Kidney Disease

Interventions

Type	Name	Description
DRUG	Sativex	Each 100 uL actuation (spray) of Sativex contains 27 mg/mL THC and 25 mg/mL CBD plus peppermint flavouring. The study dosage of 10.8 mg THC and 10 mg CBD is delivered as four sprays to the oral mucosa.

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-12-24
• Last updated: 2016-08-11