Renal InsufficiencyPhase 1NCT02325024
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.
A Phase 1 study testing Sativex in people with Renal Insufficiency and Kidney Disease, run by GW Pharmaceuticals Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Kidney Disease
- What is being tested?
- Sativex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Severe renal impairment or ESRD [clinically significantly abnormal creatinine and creatinine clearance (CLcr <30 mL/min and not requiring dialysis].
- Onset of renal impairment must be documented at least 3 months prior to study start.
- In good health as determined by medical history, physical examination, biochemistry, hematology, urinalysis, hepatitis B and C, and HIV testing.
- Creatinine clearance (CLcr) > 80 mL/min indicating normal renal function.
- Individually matched to a renally impaired subject with respect to age (within the decile or 5 years, whichever is less), gender, and BMI (+/- 10% BMI).
Who cannot join
- Subjects meeting any of the following criteria will not be eligible for this trial:
- Donation or loss of 400 mL or more of blood within eight weeks prior to dosing and unwilling to abstain from donation of blood during the study.
- Significant concomitant illness within the two weeks prior to dosing.
- At high risk for requiring hospital admission or extended hospital stay during study period or any scheduled elective hospitalization during the planned study duration.
- Requiring dialysis or expected to require dialysis during study period.
- Has any surgical or medical condition, significant disease or disorder or any finding on physical examination and/or oral examination (other than their underlying condition) which might significantly alter the absorption, distribution, metabolism or excretion of drugs or that, in the opinion of the investigator, may put the subject at risk, influence the result of the study, or the subject's ability to participate in the study.
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- History of renal transplant.
- Clinical evidence of acute or chronic liver disease or liver injury as indicated by clinically significant abnormal liver function tests such as Aspartate Aminotransferase, Alanine Aminotransferase, gamma glutamyl-transpeptidase, alkaline phosphatase (any ≥2.5 x Upper Limit of Normal [ULN] ) or serum bilirubin (≥1.5 x ULN) unless there is another likely explanation (e.g. Gilbert's syndrome).
- Any change in medication within 14 days prior to dosing or planned for anytime throughout the study which might significantly alter the absorption, distribution, metabolism or excretion of the Investigational Medicinal Product (IMP), in the opinion of the investigator.
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP(s).
- Positive result for the presence of HBsAg, HCAb, or HIV antibodies.
- Currently using or has used cannabis and/or cannabinoid-based medications (e.g. Marinol®, Nabilone®, Cannador®) within 30 days of study entry and unwilling to abstain for the duration of the study.
- Any known or suspected history of a substance abuse/dependence disorder within the 12 months prior to dosing or current use of an illicit drug or current non prescribed use of any prescription drug, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Current heavy alcohol consumption (more than 60 g of pure alcohol per day for men, and more than 40 g of pure alcohol per day for women).
- Unwilling to abstain from drinking alcohol for 24 hours prior to each visit and during the inpatient period of the study.
- Unwilling to abstain from nicotine products from midnight Day -2 to 48 hours post dose.
- Unwilling to abstain from grapefruit products for one week prior to and throughout the inpatient period.
- Consume more than five caffeinated beverages per day (e.g. five cups of tea or coffee or cans of cola) or who are unwilling to abstain from consumption of caffeine-containing food and beverages throughout the inpatient period.
- Any known or suspected history or immediate family history of schizophrenia, or other psychotic illness, history of severe personality disorder or other severe significant psychiatric disorder other than depression associated with underlying condition.
- Any history of epilepsy as evidenced by one or more seizures in the last 12 months.
- Significant cardiac disease, or has a cardiac disorder that in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction, or has a secondary or tertiary atrioventricular block, or evidence of clinically significant cardiac disease on ECG at screening.
- Sexually active males whose partner is of childbearing potential who do not agree to practice two different methods of birth control or remain truly abstinent during the study and for three months after the last dose of study medication. Sexually active females of childbearing potential who do not agree to practice two different methods of birth control or remain truly abstinent during the study and for three months after the last dose of study medication. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control implant, birth control depot injection, condom, or sponge with spermicide. However, a male condom must not be used in conjunction with a female condom as this may not prove effective.
- Note: Non-childbearing potential is defined as female subjects who are surgically sterile (i.e., have undergone bilateral salpingo-oophorectomy, hysterectomy) and female subjects who have been postmenopausal for at least 12 consecutive months.
- Pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- Received an IMP within 30 days or five times the half-life of the IMP (whichever is greater) prior to the screening visit.
- Travel outside the country of residence planned during the study.
- Previously enrolled into this study or any other Sativex® study.
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Sativex
- Keywords
- Sativex, GW-1000-02, Nabiximols, Pharmacokinetics, Renal Insufficiency, Chronic Kidney Failure
- Medical subject headings
- Renal Insufficiency, Kidney Diseases, Marijuana Abuse, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called GW-1000-02, Nabiximols, THC/CBD spray
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.
| Study group | Role | What they receive |
|---|---|---|
| Renally Impaired Subjects | Experimental | Treatment group consists of subjects with severe renal impairment or ESRD and in accordance with the following criteria;
* Clinically significantly abnormal creatinine and creatinine clearance (CLcr <30 mL/min) and not requiring dialysis.
* Onset of renal impairment must have been documented at least 3 months prior to study start. Receives: Drug: Sativex |
| Matched subjects with Normal Renal Function | Experimental | Group consists of healthy subjects (as determined by medical history, physical examination, biochemistry, hematology, urinalysis, hepatitis B and C, and HIV testing) who demonstrate normal renal function (CLcr > 80 mL/min) and are individually matched to renally impaired subjects with respect to age (within the decile or five years, whichever is less), gender, and Body Mass Index (BMI) (+/- 10% BMI). Receives: Drug: Sativex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of THC: Cmax, AUC(0-t) and AUC(0-∞)
The following are presented for THC:
- Mean maximum (peak) plasma concentration of the drug (Cmax)
- Mean area under the concentration-time curve calculated to the last observable concentration at time t (AUC(0-t))
- Mean area under the concentration-time curve from time zero to infinity (AUC(0-∞))
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 11-hydroxy-THC (11-OH-THC): Cmax, AUC(0-t) and AUC(0-∞)
The following are presented for 11-OH-THC:
- Mean Cmax
- Mean AUC(0-t)
- Mean AUC(0-∞)
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of CBD: Cmax, AUC(0-t) and AUC(0-∞)
The following are presented for CBD:
- Mean Cmax
- Mean AUC(0-t)
- Mean AUC(0-∞)
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 7-hydroxy-CBD (7-OH-CBD): Cmax, AUC(0-t) and AUC(0-∞)
The following are presented for 7-OH-CBD:
- Mean Cmax
- Mean AUC(0-t)
- Mean AUC(0-∞)
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Secondary outcomes (13)
Pharmacokinetic parameters of THC: t(1/2), tmax, CL/F, CLr and F(e,u)
The following are presented for THC;
- Mean terminal-phase elimination half-life (t(1/2))
- Mean time to maximum (peak) plasma concentration (tmax)
- Mean apparent clearance of drug from plasma (CL/F)
- Mean renal clearance (CLr)
- Mean fraction of the systemically available drug excreted into the urine (F(e,u))
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 11-OH-THC: t(1/2), tmax, CLr and F(e,u)
The following are presented for 11-OH-THC;
- Mean t(1/2)
- Mean tmax
- Mean CLr
- Mean F(e,u)
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of CBD: t(1/2), tmax, CL/F, CLr and F(e,u)
The following are presented for CBD;
- Mean t(1/2)
- Mean tmax
- Mean CL/F
- Mean CLr
- Mean F(e,u)
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 7-OH-CBD: t(1/2), tmax, CLr and F(e,u)
The following are presented for 7-OH-CBD;
- Mean t(1/2)
- Mean tmax
- Mean CLr
- Mean F(e,u)
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of THC: Cmax(u), AUC(0-t(u)), AUC(0-∞(u)) and CLu/F
The following are presented for THC:
- Mean unbound maximum (peak) plasma concentration of the drug (Cmax(u))
- Mean unbound area under the concentration-time curve calculated to the last observable concentration at time t (AUC(0-t(u)))
- Mean unbound area under the concentration-time curve from time zero to infinity (AUC(0-∞(u)))
- Mean apparent unbound clearance of drug from plasma (CLu/F)
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 11-OH-THC: Cmax(u), AUC(0-t(u)) and AUC(0-∞(u))
The following are presented for 11-OH-THC:
- Mean Cmax(u)
- Mean AUC(0-t(u))
- Mean AUC(0-∞(u))
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of CBD: Cmax(u), AUC(0-t(u)), AUC(0-∞(u)) and CLuF
The following are presented for CBD:
- Mean Cmax(u)
- Mean AUC(0-t(u))
- Mean AUC(0-∞(u))
- Mean CLu/F
Measured: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 7-OH-CBD: Cmax(u), AUC(0-t(u)) and AUC(0-∞(u))
The following are presented for 11-OH-THC:
- Mean Cmax(u)
- Mean AUC(0-t(u))
- Mean AUC(0-∞(u))
Measured: Pre-dose (t=0) and up to 48 hours post-dose
The incidence of adverse events as a measure of subject safety
The number of subjects who experienced an adverse event during the study is presented. The time-frame for adverse event reporting was from screening to the follow-up visit.
Measured: From screening to follow-up (a maximum of 24 days)
The number of subjects with a clinically significant change in physical and oral examination results, relative to pre-treatment baseline
The number of subjects with a change in physical and oral examination results indicative of an adverse event, relative to the pre-treatment baseline, is presented.
Measured: From screening to follow-up (a maximum of 24 days)
The number of subjects with a clinically significant change in 12-lead electrocardiogram (ECG) results, relative to pre-treatment baseline
The number of subjects with a change in ECG results indicative of an adverse event, relative to the pre-treatment baseline, is presented.
Measured: From screening to follow-up (a maximum of 24 days)
The number of subjects with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline
The number of subjects with clinically significant changes in serum biochemistry, hematology and urinalysis, relative to the pretreatment baseline, is presented.
Measured: From screening to follow-up (a maximum of 24 days)
The number of subjects with a clinically significant change in vital signs, relative to pre-treatment baseline
The number of subjects with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) indicative of an adverse event, relative to the pre-treatment baseline, is presented.
A clinically significant drop in blood pressure is defined as a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure associated with a clinical manifestation of postural hypotension after two minutes standing.
Measured: From screening to follow-up (a maximum of 24 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2016
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GW Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325024
- Sponsor's protocol ID
- GWCP1426
- Other IDs
- 2014-003104-67, 2014
- Status last verified
- Aug 2016
- First submitted
- 19 Dec 2014
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02325024
- Acronym / sponsor ID
- GWCP1426
- Conditions
- Renal Insufficiency, Kidney Disease
- Keywords
- Sativex, GW-1000-02, Nabiximols, Pharmacokinetics, Renal Insufficiency, Chronic Kidney Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GW Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renally Impaired Subjects | Experimental | Drug: SativexTreatment group consists of subjects with severe renal impairment or ESRD and in accordance with the following criteria; * Clinically significantly abnormal creatinine and creatinine clearance (CLcr <30 mL/min) and not requiring dialysis. * Onset of renal impairment must have been documented at least 3 months prior to study start. |
| Matched subjects with Normal Renal Function | Experimental | Drug: SativexGroup consists of healthy subjects (as determined by medical history, physical examination, biochemistry, hematology, urinalysis, hepatitis B and C, and HIV testing) who demonstrate normal renal function (CLcr > 80 mL/min) and are individually matched to renally impaired subjects with respect to age (within the decile or five years, whichever is less), gender, and Body Mass Index (BMI) (+/- 10% BMI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe renal impairment or ESRD [clinically significantly abnormal creatinine and creatinine clearance (CLcr <30 mL/min and not requiring dialysis].
- Onset of renal impairment must be documented at least 3 months prior to study start.
- In good health as determined by medical history, physical examination, biochemistry, hematology, urinalysis, hepatitis B and C, and HIV testing.
- Creatinine clearance (CLcr) > 80 mL/min indicating normal renal function.
- Individually matched to a renally impaired subject with respect to age (within the decile or 5 years, whichever is less), gender, and BMI (+/- 10% BMI).
Key exclusion criteria (27 listed)
- Donation or loss of 400 mL or more of blood within eight weeks prior to dosing and unwilling to abstain from donation of blood during the study.
- Significant concomitant illness within the two weeks prior to dosing.
- At high risk for requiring hospital admission or extended hospital stay during study period or any scheduled elective hospitalization during the planned study duration.
- Requiring dialysis or expected to require dialysis during study period.
- Has any surgical or medical condition, significant disease or disorder or any finding on physical examination and/or oral examination (other than their underlying condition) which might significantly alter the absorption, distribution, metabolism or excretion of drugs or that, in the opinion of the investigator, may put the subject at risk, influence the result of the study, or the subject's ability to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SativexAlso: GW-1000-02, Nabiximols, THC/CBD sprayEach 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. | Drug | Matched subjects with Normal Renal Function, Renally Impaired Subjects |
Primary outcome
Pharmacokinetic parameters of THC: Cmax, AUC(0-t) and AUC(0-∞)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
The following are presented for THC: * Mean maximum (peak) plasma concentration of the drug (Cmax) * Mean area under the concentration-time curve calculated to the last observable concentration at time t (AUC(0-t)) * Mean area under the concentration-time curve from time zero to infinity (AUC(0-∞))
Pharmacokinetic parameters of 11-hydroxy-THC (11-OH-THC): Cmax, AUC(0-t) and AUC(0-∞)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
The following are presented for 11-OH-THC: * Mean Cmax * Mean AUC(0-t) * Mean AUC(0-∞)
Pharmacokinetic parameters of CBD: Cmax, AUC(0-t) and AUC(0-∞)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
The following are presented for CBD: * Mean Cmax * Mean AUC(0-t) * Mean AUC(0-∞)
Pharmacokinetic parameters of 7-hydroxy-CBD (7-OH-CBD): Cmax, AUC(0-t) and AUC(0-∞)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
The following are presented for 7-OH-CBD: * Mean Cmax * Mean AUC(0-t) * Mean AUC(0-∞)
13 secondary outcomes
Pharmacokinetic parameters of THC: t(1/2), tmax, CL/F, CLr and F(e,u)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 11-OH-THC: t(1/2), tmax, CLr and F(e,u)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of CBD: t(1/2), tmax, CL/F, CLr and F(e,u)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 7-OH-CBD: t(1/2), tmax, CLr and F(e,u)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of THC: Cmax(u), AUC(0-t(u)), AUC(0-∞(u)) and CLu/F
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 11-OH-THC: Cmax(u), AUC(0-t(u)) and AUC(0-∞(u))
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of CBD: Cmax(u), AUC(0-t(u)), AUC(0-∞(u)) and CLuF
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
Pharmacokinetic parameters of 7-OH-CBD: Cmax(u), AUC(0-t(u)) and AUC(0-∞(u))
Time frame: Pre-dose (t=0) and up to 48 hours post-dose
The incidence of adverse events as a measure of subject safety
Time frame: From screening to follow-up (a maximum of 24 days)
The number of subjects with a clinically significant change in physical and oral examination results, relative to pre-treatment baseline
Time frame: From screening to follow-up (a maximum of 24 days)
The number of subjects with a clinically significant change in 12-lead electrocardiogram (ECG) results, relative to pre-treatment baseline
Time frame: From screening to follow-up (a maximum of 24 days)
The number of subjects with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline
Time frame: From screening to follow-up (a maximum of 24 days)
The number of subjects with a clinically significant change in vital signs, relative to pre-treatment baseline
Time frame: From screening to follow-up (a maximum of 24 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sativex in people with Renal Insufficiency and Kidney Disease, run by GW Pharmaceuticals Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic parameters of THC: Cmax, AUC(0-t) and AUC(0-∞) (time frame: Pre-dose (t=0) and up to 48 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.