Healthy SubjectsPhase 1NCT02325011
An Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.
A Phase 1 study testing Sativex® (Treatment A) and Sativex® and fluconazole concomitantly (Treatment B) in people with Healthy Subjects, run by Jazz Pharmaceuticals at 1 site in United States.
Trial summary
The study aims to evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) in healthy subjects with a history of cannabis use. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Sativex® (Treatment A) and Sativex® and fluconazole concomitantly (Treatment B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Feb 2015
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For inclusion in the study subjects must fulfill ALL of the following criteria:
- Willing and able to give written informed consent for participation in the study.
- Healthy, male or female, between 18 and 45 years of age (inclusive).
- Previous experience with cannabis; "cannabis experience" is defined as use of cannabis in the past, but not within 12 months prior to entry into the study.
- Able (in the investigator's opinion) and willing to comply with all study requirements.
- Willing and able to communicate with the investigator.
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- Vital signs at screening (after five minutes resting measured in the supine position) within the following ranges:
- Body temperature between 35.0 to 37.5 °C
- Systolic blood pressure, 90 to 150 mmHg*
- Diastolic blood pressure, 60 to 90 mmHg*
- Pulse rate, 40 to 99 beats per minute*. (*Blood pressure and pulse rate 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).
- Body mass index (BMI) between 18-30 kg/m2 (both inclusive) as calculated by the following BMI formula: Weight (kg) ÷ [Height (m)]2
- Willing for his or her name to be reported to the responsible authorities for participation in this study, as applicable in individual countries.
- Willing to allow his or her primary care practitioner and consultant to be notified of participation in the study.
Who cannot join
- The subject may not enter the study if ANY of the following apply:
- Donation or loss of 400 mL or more of blood within eight weeks prior to first dosing (Visit 2) and unwilling to abstain from donation of blood during the study.
- Significant concomitant illness within the two weeks prior to first dosing (Visit 2).
- At risk for requiring hospital admission or extended hospital stay during the study or any scheduled elective hospitalization during the planned study duration.
- Has any surgical or medical condition, significant disease or disorder or any finding on physical examination and/or oral examination 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 subjects' ability to participate in the study.
- 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 upper limit of normal [ULN]) or serum bilirubin (≥1.5 ULN) unless there is another more likely explanation (eg, Gilbert's syndrome).
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- Significant renal disease or significantly impaired renal function with an estimated creatinine clearance below 50 mL/min.
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP, Sativex.
- Have a history of known hypersensitivity or idiosyncratic reaction to fluconazole, its excipients, or related compounds.
- Positive result for the presence of hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCAb), or HIV I or II antibodies.
- Currently using or has used cannabis and/or cannabinoid based medications (eg, Marinol®, Nabilone®, Cannador®) or Acomplia (rimonabant) or taranabant within 12 months prior to first dosing (Visit 2) and is unwilling to abstain for the duration of the study.
- Currently using or has used an illicit drug or non prescribed use of any prescription drug within 12 months prior to first dosing (Visit 2) and is 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 first dosing (Visit 2).
- Has a positive urine drug (including THC) or alcohol result at screening or on Day -1 of Visit 2.
- 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 during this study (for 24 hours prior to, and for the duration of, each study visit).
- Had any treatment with any known enzyme-altering agents (barbiturates, phenothiazines, cimetidine, etc.) within 30 days prior to first dosing (Visit 2) or during the study.
- Unwilling to abstain from nicotine products from midnight Day -1 to 48 hours postdose for each Inpatient Period.
- Unwilling to abstain from grapefruit products for one week prior to and throughout the Inpatient Period.
- Have had substantial changes in eating habits, per the investigator's opinion, within 30 days prior to screening.
- Consume more than five caffeinated beverages per day (eg, 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 each 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 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 highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. Sexually active females of childbearing potential who do not agree to practice two highly effective methods of birth control or remain abstinent during the study and for three months after the last dose of IMP. If employing birth control, two of the following precautions must be used: established use of oral, transdermal, injected or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system (consideration should be given to the type of device or system being used, as there are higher failure rates quoted for certain types, eg, steel or copper wire); Condoms with spermicidal foam/ gel/ film/ cream/ suppository; the use of a condom should always be supplemented with the use of a spermicide. Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). True abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
- Note: Non-childbearing potential is defined as female subjects who are surgically sterile (ie, 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 t½ of the IMP (whichever is greater) prior to the Screening Visit.
- Travel outside the country of residence planned during the study.
- Use of any prescription medication or over-the-counter medication within 14 days prior to Screening or during the study.
- Previously enrolled in this study or another Sativex study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, Single-Dose, Two-Sequence, Two-Treatment, Four-Period, Crossover Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.
The study aims to evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) in healthy subjects with a history of cannabis use.
The primary clinical hypothesis is that no drug-drug interaction between Sativex® and fluconazole will be detected as effects on PK parameters of Sativex®, when both are administered to healthy human volunteers who have experience using cannabis.
The study additionally aims to evaluate the safety and tolerability of an oromucosal dose of Sativex® in subjects when given concurrently with fluconazole.
Read the detailed description
This is a Phase I, open-label, randomized, single-dose, two-sequence, two-treatment, four-period, crossover study to evaluate the effects of fluconazole on the PK of Sativex® in healthy subjects with cannabis experience.
Subjects will be randomly assigned to one of the two treatment sequences. Each sequence has four Inpatient Periods. During each Inpatient Period, a subject will either receive a single dose of Sativex® alone (Treatment A) or a single-dose Sativex® coadministered with the interaction drug, fluconazole (Treatment B). The crossover treatments will be separated by a washout period of at least 10 days, but no more than 12 days, between each Sativex® dose.
Specifically in both Treatments A and B, a single oromucosal dose of Sativex® (10.8 mg THC and 10 mg CBD delivered in four sprays) will be administered in a fasted state on Day 1 within each Inpatient Period. During Treatment B, fluconazole 200 mg twice daily (BID) for two days, will be administered at the following time points relative to the Day 1 Sativex® dose: 1 hour pre-dose, and approximately 11, 24, and 36 hours post-dose.
Subjects will be checking into the clinical research facility on Day 1 for each Inpatient Period. Subjects will be confined to the clinical research facility during each Inpatient Period, remaining in the clinical unit after dosing under observation through the collection of all PK blood samples. Fifteen PK blood samples will be taken per subject during each study period: prior to Sativex® dosing (t=0) and at the following multiple time points after dosing: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours; along with some select samples for fluconazole measurements (Day 1 and 2 pre-fluconazole morning dose, 4 hours and 8 hours post-fluconazole morning dose). Subjects will be discharged from the unit after the 48-hour post-dose PK sample and samples for clinical laboratory tests and vital signs have been taken and the subject is determined to be fit for discharge.
A Safety Follow-Up Visit will be performed 7 (+2) days after last Inpatient period.
The expected duration for study participation (including Screening Visit, Inpatient Periods, and Safety Follow-up Visit) for each individual subject is a maximum of 61 days.
- Conditions
- Healthy Subjects
- Being tested
- Sativex® (Treatment A), Sativex® and fluconazole concomitantly (Treatment B)
- Keywords
- Sativex, GW-1000-02, Nabiximols, Fluconazole, Pharmacokinetics, Drug-drug interaction
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sativex® (Treatment A)Drug
Also called Nabiximols, GW-1000-02, 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.
Sativex® and fluconazole concomitantly (Treatment B)Drug
Also called Nabiximols, GW-1000-02, 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.
Fluconazole 200 mg twice daily (BID) for two days, will be administered at the following time points relative to the Day 1 Sativex dose: 1 hour pre-dose, and approximately 11, 24, and 36 hours post-dose.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | During each of the four Inpatient Periods (Visit 2 to Visit 5 inclusive), healthy subjects with a history of cannabis use will either receive a single dose of Sativex® alone (Treatment A) or a single-dose of Sativex coadministered with the interaction drug, fluconazole (Treatment B) on a repeated, cross-over basis.
Subjects will be randomly assigned to one of two treatment sequences. Treatment sequence 1 is as follows;
* Visit 2 (Treatment A)
* Visit 3 (Treatment B)
* Visit 4 (Treatment A)
* Visit 5 (Treatment B)
The crossover treatments will be separated by a washout period of at least 10 days, but no more than 12 days, between each Sativex® dose. Receives: Drug: Sativex® (Treatment A); Drug: Sativex® and fluconazole concomitantly (Treatment B) |
| Treatment Sequence 2 | Experimental | During each of the four Inpatient Periods (Visit 2 to Visit 5 inclusive), healthy subjects with a history of cannabis use will either receive a single dose of Sativex® alone (Treatment A) or a single-dose of Sativex coadministered with the interaction drug, fluconazole (Treatment B) on a repeated, cross-over basis.
Subjects will be randomly assigned to one of two treatment sequences. Treatment sequence 2 is as follows;
* Visit 2 (Treatment B)
* Visit 3 (Treatment A)
* Visit 4 (Treatment B)
* Visit 5 (Treatment A)
The crossover treatments will be separated by a washout period of at least 10 days, but no more than 12 days, between each Sativex® dose. Receives: Drug: Sativex® (Treatment A); Drug: Sativex® and fluconazole concomitantly (Treatment B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of Δ9 Tetrahydrocannabinol (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 (for each of the four treatment periods)
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 (for each of the four treatment periods)
Pharmacokinetic parameters of Cannabidiol (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 (for each of the four treatment periods)
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 (for each of the four treatment periods)
Secondary outcomes (9)
Pharmacokinetic parameters of THC: t(1/2), tmax and CL/F
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)
Measured: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
Pharmacokinetic parameters of 11-OH-THC: t(1/2) and tmax
The following are presented for 11-OH-THC;
- Mean t(1/2)
- Mean tmax
Measured: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
Pharmacokinetic parameters of CBD: t(1/2), tmax and CL/F
The following are presented for CBD;
- Mean t(1/2)
- Mean tmax
- Mean CL/F
Measured: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
Pharmacokinetic parameters of 7-OH-CBD: t(1/2) and tmax
The following are presented for 7-OH-CBD;
- Mean t(1/2)
- Mean tmax
Measured: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
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 61 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 61 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 61 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, haematology and urinalysis, relative to the pretreatment baseline, is presented.
Measured: From screening to follow-up (a maximum of 61 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 61 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 startNov 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 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
- NCT02325011
- Sponsor's protocol ID
- GWCP1427
- Other IDs
- 2014-003105-16, 2014
- Status last verified
- Dec 2022
- First submitted
- 19 Dec 2014
- 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, Randomized, Single-Dose, Two-Sequence, Two-Treatment, Four-Period, Crossover Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.
- ClinicalTrials.gov ID
- NCT02325011
- Acronym / sponsor ID
- GWCP1427
- Conditions
- Healthy Subjects
- Keywords
- Sativex, GW-1000-02, Nabiximols, Fluconazole, Pharmacokinetics, Drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- 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 evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) in healthy subjects with a history of cannabis use.
The primary clinical hypothesis is that no drug-drug interaction between Sativex® and fluconazole will be detected as effects on PK parameters of Sativex®, when both are administered to healthy human volunteers who have experience using cannabis.
The study additionally aims to evaluate the safety and tolerability of an oromucosal dose of Sativex® in subjects when given concurrently with fluconazole.
Detailed description
This is a Phase I, open-label, randomized, single-dose, two-sequence, two-treatment, four-period, crossover study to evaluate the effects of fluconazole on the PK of Sativex® in healthy subjects with cannabis experience.
Subjects will be randomly assigned to one of the two treatment sequences. Each sequence has four Inpatient Periods. During each Inpatient Period, a subject will either receive a single dose of Sativex® alone (Treatment A) or a single-dose Sativex® coadministered with the interaction drug, fluconazole (Treatment B). The crossover treatments will be separated by a washout period of at least 10 days, but no more than 12 days, between each Sativex® dose.
Specifically in both Treatments A and B, a single oromucosal dose of Sativex® (10.8 mg THC and 10 mg CBD delivered in four sprays) will be administered in a fasted state on Day 1 within each Inpatient Period. During Treatment B, fluconazole 200 mg twice daily (BID) for two days, will be administered at the following time points relative to the Day 1 Sativex® dose: 1 hour pre-dose, and approximately 11, 24, and 36 hours post-dose.
Subjects will be checking into the clinical research facility on Day 1 for each Inpatient Period. Subjects will be confined to the clinical research facility during each Inpatient Period, remaining in the clinical unit after dosing under observation through the collection of all PK blood samples. Fifteen PK blood samples will be taken per subject during each study period: prior to Sativex® dosing (t=0) and at the following multiple time points after dosing: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours; along with some select samples for fluconazole measurements (Day 1 and 2 pre-fluconazole morning dose, 4 hours and 8 hours post-fluconazole morning dose). Subjects will be discharged from the unit after the 48-hour post-dose PK sample and samples for clinical laboratory tests and vital signs have been taken and the subject is determined to be fit for discharge.
A Safety Follow-Up Visit will be performed 7 (+2) days after last Inpatient period.
The expected duration for study participation (including Screening Visit, Inpatient Periods, and Safety Follow-up Visit) for each individual subject is a maximum of 61 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: Sativex® (Treatment A), Drug: Sativex® and fluconazole concomitantly (Treatment B)During each of the four Inpatient Periods (Visit 2 to Visit 5 inclusive), healthy subjects with a history of cannabis use will either receive a single dose of Sativex® alone (Treatment A) or a single-dose of Sativex coadministered with the interaction drug, fluconazole (Treatment B) on a repeated, cross-over basis. Subjects will be randomly assigned to one of two treatment sequences. Treatment sequence 1 is as follows; * Visit 2 (Treatment A) * Visit 3 (Treatment B) * Visit 4 (Treatment A) * Visit 5 (Treatment B) The crossover treatments will be separated by a washout period of at least 10 days, but no more than 12 days, between each Sativex® dose. |
| Treatment Sequence 2 | Experimental | Drug: Sativex® (Treatment A), Drug: Sativex® and fluconazole concomitantly (Treatment B)During each of the four Inpatient Periods (Visit 2 to Visit 5 inclusive), healthy subjects with a history of cannabis use will either receive a single dose of Sativex® alone (Treatment A) or a single-dose of Sativex coadministered with the interaction drug, fluconazole (Treatment B) on a repeated, cross-over basis. Subjects will be randomly assigned to one of two treatment sequences. Treatment sequence 2 is as follows; * Visit 2 (Treatment B) * Visit 3 (Treatment A) * Visit 4 (Treatment B) * Visit 5 (Treatment A) The crossover treatments will be separated by a washout period of at least 10 days, but no more than 12 days, between each Sativex® dose. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Willing and able to give written informed consent for participation in the study.
- Healthy, male or female, between 18 and 45 years of age (inclusive).
- Previous experience with cannabis; "cannabis experience" is defined as use of cannabis in the past, but not within 12 months prior to entry into the study.
- Able (in the investigator's opinion) and willing to comply with all study requirements.
- Willing and able to communicate with the investigator.
Key exclusion criteria (31 listed)
- Donation or loss of 400 mL or more of blood within eight weeks prior to first dosing (Visit 2) and unwilling to abstain from donation of blood during the study.
- Significant concomitant illness within the two weeks prior to first dosing (Visit 2).
- At risk for requiring hospital admission or extended hospital stay during the study or any scheduled elective hospitalization during the planned study duration.
- Has any surgical or medical condition, significant disease or disorder or any finding on physical examination and/or oral examination 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 subjects' ability to participate in the study.
- 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 upper limit of normal [ULN]) or serum bilirubin (≥1.5 ULN) unless there is another more likely explanation (eg, Gilbert's syndrome).
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 |
|---|---|---|
| Sativex® (Treatment A)Also: Nabiximols, GW-1000-02, 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 | Treatment Sequence 1, Treatment Sequence 2 |
| Sativex® and fluconazole concomitantly (Treatment B)Also: Nabiximols, GW-1000-02, 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. Fluconazole 200 mg twice daily (BID) for two days, will be administered at the following time points relative to the Day 1 Sativex dose: 1 hour pre-dose, and approximately 11, 24, and 36 hours post-dose. | Drug | Treatment Sequence 1, Treatment Sequence 2 |
Primary outcome
Pharmacokinetic parameters of Δ9 Tetrahydrocannabinol (THC): Cmax, AUC(0-t) and AUC(0-∞)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
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 (for each of the four treatment periods)
The following are presented for 11-OH-THC: * Mean Cmax * Mean AUC(0-t) * Mean AUC(0-∞)
Pharmacokinetic parameters of Cannabidiol (CBD): Cmax, AUC(0-t) and AUC(0-∞)
Time frame: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
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 (for each of the four treatment periods)
The following are presented for 7-OH-CBD: * Mean Cmax * Mean AUC(0-t) * Mean AUC(0-∞)
9 secondary outcomes
Pharmacokinetic parameters of THC: t(1/2), tmax and CL/F
Time frame: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
Pharmacokinetic parameters of 11-OH-THC: t(1/2) and tmax
Time frame: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
Pharmacokinetic parameters of CBD: t(1/2), tmax and CL/F
Time frame: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
Pharmacokinetic parameters of 7-OH-CBD: t(1/2) and tmax
Time frame: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)
The incidence of adverse events as a measure of subject safety
Time frame: From screening to follow-up (a maximum of 61 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 61 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 61 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 61 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 61 days)
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.
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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.
1 site 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® (Treatment A) and Sativex® and fluconazole concomitantly (Treatment B) in people with Healthy Subjects, run by Jazz Pharmaceuticals at 1 site 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 14 inclusion and 31 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 1 site 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 parameters of Δ9 Tetrahydrocannabinol (THC): Cmax, AUC(0-t) and AUC(0-∞) (time frame: Pre-dose (t=0) and up to 48 hours post-dose (for each of the four treatment periods)). 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 20 Dec 2022.