Hepatic ImpairmentPhase 1NCT01887301
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase 1 study testing Sativex in people with Hepatic Impairment, run by Jazz Pharmaceuticals at 2 sites in United States.
Trial summary
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in healthy patients and those with hepatic (liver) function impairment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- 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
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to May 2014
- 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
- Subject is aged 18 years or above.
- Subject is willing and able to give informed consent for participation in the study (see Section 14.2).
- Male or female subjects.
- All females must have negative pregnancy test results at screening and baseline.
- Vital signs (after five minutes resting measured in the supine position) must be within the following ranges:
- Body temperature between 35.0-37.5 °C
Show all 31Show fewer
- Systolic blood pressure, 90-150 mmHg
- Diastolic blood pressure, 60-90 mmHg
- Pulse rate, 40-99 beats per minute (bpm) Blood pressure and pulse will be taken again in a standing position. After two minutes standing, there shall be no more than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure, associated with clinical manifestation of postural hypotension.
- Subjects must weigh at least 50 kg and have a BMI between 19 and 42 kg/m2 to participate in this study.
- Patients with impaired hepatic function must be compliantly on a stable dose of medication and/or treatment regimen (in the opinion of the investigator) for at least 4 weeks prior to the dosing day with no foreseeable plans for change.
- Subject is able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing and able to communicate well with the Investigator.
- Subject is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries.
- Subject is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
- Groups 1 and 2 (mild and moderate hepatic impairment)
- Clinical features consistent with a confirmed clinical diagnosis of mild and moderate liver impairment.
- Child-Pugh clinical assessment score consistent with degree of hepatic impairment.
- Clinical evidence of stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days, as documented by the patients' recent medical history.
- Otherwise considered healthy in general as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening.
- Platelet count > 50,000 X 109/L at screening and baseline.
- Willing to maintain a stable dose of any, not prohibited, medication throughout the study.
- Group 3 (severe hepatic impairment)
- Patients presenting at least one clinical sign consistent with a clinical diagnosis of severe liver impairment.
- Child-Pugh clinical assessment score consistent with degree of hepatic impairment.
- Platelet count > 30,000 X 109/L at screening and baseline.
- Willing to maintain a stable dose of any, not prohibited, medication throughout the study.
- Group 4 (healthy controls)
- In good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening.
- Healthy male or female subjects, matched with respect to age (±10 years), weight (±10% BMI) and sex to the severe or most severe evaluable patients.
- No clinical evidence of liver disease or liver injury as indicated by clinically significant abnormal liver function tests such as aspartate aminotransferase, alanine aminotransferase, γ-glutamyl-transpeptidase, alkaline phosphatase, or serum bilirubin two times above the upper limit of the normal range.
Who cannot join
- Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
- Significant concomitant illness within the two weeks prior to dosing.
- Resting heart rate <40 bpm.
- History of autonomic dysfunction.
- History of clinically significant drug allergy; a known hypersensitivity to the study drug or drugs similar to the study drug.
- Any surgical or medical condition (other than hepatic impairment) which might significantly alter the absorption, distribution, metabolism or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
Show all 41Show fewer
- Any history of significant bleeding and haemorrhagic tendencies. However, subjects with a history of bleeding tendencies secondary to hepatic impairment will be excluded based on Principal Investigators' discretion.
- History of immunocompromisation, including known history of human immunodeficiency virus seropositivity.
- History of drug abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Unwilling to abstain from alcohol during this study.
- Currently receiving a prohibited or restricted medication and unwilling to stop or comply with restriction for 14 days prior to the screening visit and for the duration of the study.
- Currently using or has used cannabis, cannabinoid-based medications (e.g. Marinol, Nabilone, Cannador), or Acomplia (rimonabant) or taranabant within 30 days of study entry and unwilling to abstain for the duration of the study.
- A known or suspected history or family history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with underlying condition.
- A history of uncontrolled epilepsy as evidenced by one or more seizures in the last 12 months.
- Significant cardiac disease, e.g. has experienced myocardial infarction (MI) (if the screening ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the subject can enter the study at the discretion of the Investigator and/or local medical monitor) or clinically relevant cardiac dysfunction within the last six months, or any of the following within the last six months:
- had a coronary artery bypass surgery or percutaneous coronary intervention,
- has unstable angina or has had stroke,
- unstable heart insufficiency (New York Heart Association grade III-IV),
- has a cardiac disorder that, in the opinion of the Investigator, would put the subject at risk of a clinically relevant arrhythmia or MI, or has a secondary or tertiary atrioventricular block.
- Had liver surgery (including transplantation) within the last six months.
- Has significant renal disease or significantly impaired renal function with a creatinine clearance below 50 mL/min for Group 1 and 2, or below 40 mL/min for Group 3.
- Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier or intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective).
- Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- Any clinically significant abnormal findings in physical or oral examination, ECG or laboratory evaluations (not consistent with known clinical disease) which, in the opinion of the Investigator, may put the subject at risk, influence the result of the study, or the subjects' ability to participate in the study.
- Subjects who are unwilling to abstain from smoking from midnight on Day -1 to four hours post dose Day 1.
- Subjects who 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 period of in-patient confinement.
- Unwilling to abstain from donation of blood during the study.
- Travel outside the country of residence planned during the study.
- Subjects previously enrolled into this study.
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal product (IMP).
- Subjects who have received an IMP within 30 days or five times the half-life of the IMP (whichever is greater) prior to the screening visit.
- Groups 1, 2, and 3 (hepatic impairment)
- Symptoms or history of Stage III or worse degree of encephalopathy.
- Clinical evidence of severe ascites.
- Any evidence of acute progressive liver disease.
- Patients with clinically abnormal prothrombin time will be excluded based on the Principal Investigators' discretion.
- Group 4 (healthy controls)
- A positive Hepatitis B surface antigen or Hepatitis C test result.
- History of alcohol abuse within the 12 months prior to dosing or evidence of such abuse, as indicated by the laboratory assays conducted during the screening or baseline evaluations.
- Use of any prescription medication within 14 days prior to dosing except for hormonal contraceptives.
- Use of over-the-counter medications or vitamins within 14 days prior to dosing (except for the occasional use of paracetamol).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials, LLC
Anaheim, California, CA 92801
Clinical Pharmacology of Miami, Inc.
Miami, Florida, FL 33014-3616
About this study
Official title: An Open Label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics and Tolerability of a Single Oromucosal Dose of 4 Sprays of Sativex(Containing 10.8 mg Delta-9-tetrahydrocannabinol [THC] and 10 mg Cannabidiol [CBD]) in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function.
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in healthy patients and those with hepatic (liver) function impairment.
- Conditions
- Hepatic Impairment
- Being tested
- Sativex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SativexDrug
Also called Nabiximols, GW1000-02, THC/CBD spray
Patients receive four sprays (each 100 uL) of Sativex to the oral mucosa, which contain 10.8 mg THC and 10 mg CBD in total.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: mild hepatic impairment | Active comparator | Mild hepatic impairment: eight patients of Child-Pugh Grade A (Score 5-6). All patients received Sativex treatment. Receives: Drug: Sativex |
| Group 2: Moderate hepatic impairment | Active comparator | Moderate hepatic impairment: eight patients of Child-Pugh Grade B (Score 7-9). All patients received Sativex treatment. Receives: Drug: Sativex |
| Group 3: Pugh Grade B (Score 7-9). | Experimental | Severe hepatic impairment: eight patients of Child-Pugh Grade C (Score 10-15). All patients received Sativex treatment. Receives: Drug: Sativex |
| Group 4: Control group | Active comparator | Control Group: eight healthy subjects matched with respect to age (±10 years), weight (±10% body mass index [BMI]) and sex to the severe or most severe evaluable patients. All patients received Sativex treatment. Receives: Drug: Sativex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic analysis - Unbound maximum plasma concentration (Cmax(u)) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of unbound THC, CBD, 11-hydroxy-THC (11-OH-THC), 6-hydroxy-CBD (6-OH-CBD) and 7-hydroxy-CBD (7-OH-CBD).
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Unbound area under the concentration-time curve calculated to the last observable concentration at time t (AUC0-t(u)) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of unbound THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Unbound Area under the concentration-time curve from time zero to infinity (AUC0-inf(u)) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of unbound THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Secondary outcomes (7)
Pharmacokinetic analysis - Maximum (peak) plasma concentration (Cmax) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Area under the concentration-time curve calculated to the last observable concentration at time t (AUC0-t) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Area under the concentration-time curve from time zero to infinity (AUC0-inf) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Half-Life (t1/2) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - time to peak concentration (Tmax) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Apparent unbound clearance of drug from plasma (CL(u)/F) of Sativex® in healthy patients and in patients with hepatic impairment
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of THC, CBD.
Measured: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Incidence of adverse events during the study
Any adverse changes in the patients' medical condition following completion of the consent form were recorded on the case report forma as adverse events. The number of patients who experienced an adverse event is presented.
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887301
- Sponsor's protocol ID
- GWCP10114
- Status last verified
- Dec 2022
- First submitted
- 24 Jun 2013
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-dose, Parallel Group Study to Assess the Pharmacokinetics and Tolerability of a Single Oromucosal Dose of 4 Sprays of Sativex(Containing 10.8 mg Delta-9-tetrahydrocannabinol [THC] and 10 mg Cannabidiol [CBD]) in Patients With Impaired Hepatic Function and Healthy Subjects With Normal Hepatic Function.
- ClinicalTrials.gov ID
- NCT01887301
- Acronym / sponsor ID
- GWCP10114
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 26 Jun 2013 (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.
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in healthy patients and those with hepatic (liver) function impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: mild hepatic impairment | Active comparator | Drug: SativexMild hepatic impairment: eight patients of Child-Pugh Grade A (Score 5-6). All patients received Sativex treatment. |
| Group 2: Moderate hepatic impairment | Active comparator | Drug: SativexModerate hepatic impairment: eight patients of Child-Pugh Grade B (Score 7-9). All patients received Sativex treatment. |
| Group 3: Pugh Grade B (Score 7-9). | Experimental | Drug: SativexSevere hepatic impairment: eight patients of Child-Pugh Grade C (Score 10-15). All patients received Sativex treatment. |
| Group 4: Control group | Active comparator | Drug: SativexControl Group: eight healthy subjects matched with respect to age (±10 years), weight (±10% body mass index [BMI]) and sex to the severe or most severe evaluable patients. All patients received Sativex treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Subject is aged 18 years or above.
- Subject is willing and able to give informed consent for participation in the study (see Section 14.2).
- Male or female subjects.
- All females must have negative pregnancy test results at screening and baseline.
- Vital signs (after five minutes resting measured in the supine position) must be within the following ranges:
Key exclusion criteria (41 listed)
- Donation or loss of 400 mL or more of blood within eight weeks prior to dosing.
- Significant concomitant illness within the two weeks prior to dosing.
- Resting heart rate <40 bpm.
- History of autonomic dysfunction.
- History of clinically significant drug allergy; a known hypersensitivity to the study drug or drugs similar to the study drug.
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: Nabiximols, GW1000-02, THC/CBD sprayPatients receive four sprays (each 100 uL) of Sativex to the oral mucosa, which contain 10.8 mg THC and 10 mg CBD in total. | Drug | Group 1: mild hepatic impairment, Group 2: Moderate hepatic impairment, Group 3: Pugh Grade B (Score 7-9)., Group 4: Control group |
Primary outcome
Pharmacokinetic analysis - Unbound maximum plasma concentration (Cmax(u)) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of unbound THC, CBD, 11-hydroxy-THC (11-OH-THC), 6-hydroxy-CBD (6-OH-CBD) and 7-hydroxy-CBD (7-OH-CBD).
Pharmacokinetic analysis - Unbound area under the concentration-time curve calculated to the last observable concentration at time t (AUC0-t(u)) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of unbound THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
Pharmacokinetic analysis - Unbound Area under the concentration-time curve from time zero to infinity (AUC0-inf(u)) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
All blood samples will be taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. For pharmacokinetic (PK) assessments, blood will be drawn from each patient into a five mL lithium-heparinised tube at the following intervals (±five min): Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose. Collected blood samples will be used to confirm correct dosing, and to provide information about the plasma concentrations of unbound THC, CBD, 11-OH-THC, 6-OH-CBD and 7-OH-CBD.
7 secondary outcomes
Pharmacokinetic analysis - Maximum (peak) plasma concentration (Cmax) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Area under the concentration-time curve calculated to the last observable concentration at time t (AUC0-t) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Area under the concentration-time curve from time zero to infinity (AUC0-inf) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Half-Life (t1/2) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - time to peak concentration (Tmax) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Pharmacokinetic analysis - Apparent unbound clearance of drug from plasma (CL(u)/F) of Sativex® in healthy patients and in patients with hepatic impairment
Time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.
Incidence of adverse events during the study
Time frame: Days 1-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
Related trials for Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Hepatic Impairment
RecruitingPhase 1
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Hepatic Impairment
Not yet recruitingPhase 1
Aleniglipron Hepatic Impairment Study
Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sativex in people with Hepatic Impairment, run by Jazz Pharmaceuticals at 2 sites in United States.
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 31 inclusion and 41 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: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 analysis - Unbound maximum plasma concentration (Cmax(u)) of Sativex® in healthy patients and in patients with hepatic impairment (time frame: Pre-dose (0),0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 11, 24, 36 and 48 hours post dose.). The study lists 3 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 20 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.